Treats documented iron deficiency. NDA 17441, held by Allergan. Iron Dextran.
As of Nov 13, 2026, NDA 17441 (Infed), held by Allergan, was first approved by FDA on Apr 29, 1974, with 145 approved supplements and 0 published complete response letters.
INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response to oral iron.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 1974 | Original applicationNew formulation or manufacturer · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| InfedEQ 100MG IRON/2ML (EQ 50MG IRON/ML) · injectable;injection | Iron Dextran | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 1, 2024 | Supplement 181Labeling · Standard review | Approved | |
| Sep 14, 2021 | Supplement 180Labeling · Standard review | Approved | |
| Apr 20, 2021 | Supplement 179Labeling · Standard review | Approved | |
| Sep 11, 2020 | Supplement 178Labeling · Standard review | Approved | |
| Aug 12, 2009 | Supplement 171Labeling · Standard review | Approved | |
| Nov 26, 2002 | Supplement 164Manufacturing · Priority review | Approved | None posted |
| Nov 20, 2001 | Supplement 162Manufacturing · Priority review | Approved | None posted |
| Jul 24, 2001 | Supplement 160Manufacturing · Priority review | Approved | None posted |
| Jul 23, 2001 | Supplement 159Manufacturing · Priority review | Approved | None posted |
| Apr 18, 2001 | Supplement 161Labeling · Standard review | Approved | |
| Sep 13, 1999 | Supplement 158Manufacturing · Priority review | Approved | None posted |
| Apr 15, 1999 | Supplement 157Manufacturing · Priority review | Approved | None posted |
| Jan 13, 1999 | Supplement 154Manufacturing · Priority review | Approved | None posted |
| Jan 13, 1999 | Supplement 155Manufacturing · Priority review | Approved | None posted |
| May 22, 1998 | Supplement 153Manufacturing · Priority review | Approved | None posted |
| Apr 4, 1997 | Supplement 150Labeling · Standard review | Approved | None posted |
| Apr 4, 1997 | Supplement 151Labeling · Standard review | Approved | None posted |
| Feb 21, 1997 | Supplement 152Manufacturing · Priority review | Approved | None posted |
| Aug 11, 1995 | Supplement 149Manufacturing · Priority review | Approved | None posted |
| Apr 13, 1994 | Supplement 148Labeling · Standard review | Approved | None posted |
| Apr 12, 1994 | Supplement 146Manufacturing · Priority review | Approved | None posted |
| Apr 22, 1992 | Supplement 145Manufacturing · Priority review | Approved | None posted |
| Aug 5, 1991 | Supplement 144Labeling | Approved | None posted |
| Jul 12, 1991 | Supplement 141Manufacturing · Priority review | Approved | None posted |
| Jul 12, 1991 | Supplement 142Manufacturing · Priority review | Approved | None posted |
| Jul 12, 1991 | Supplement 143Labeling | Approved | None posted |
| Jan 12, 1988 | Supplement 139Labeling | Approved | None posted |
| Apr 7, 1986 | Supplement 138Manufacturing · Priority review | Approved | None posted |
| May 13, 1985 | Supplement 137Labeling | Approved | None posted |
| Jun 17, 1981 | Supplement 135Labeling | Approved | None posted |
| Jun 15, 1981 | Supplement 132Labeling | Approved | None posted |
| Jun 15, 1981 | Supplement 133Labeling | Approved | None posted |
| Jun 15, 1981 | Supplement 134Labeling | Approved | None posted |
| Mar 5, 1981 | Supplement 129Labeling | Approved | None posted |
| Mar 5, 1981 | Supplement 130Labeling | Approved | None posted |
| Feb 18, 1981 | Supplement 131Labeling | Approved | None posted |
| Feb 3, 1981 | Supplement 128Labeling | Approved | None posted |
| Jan 16, 1981 | Supplement 127Labeling | Approved | None posted |
| Aug 20, 1980 | Supplement 126Labeling | Approved | None posted |
| Aug 20, 1980 | Supplement 125Labeling | Approved | None posted |
| Jul 7, 1980 | Supplement 121Labeling | Approved | None posted |
| Apr 1, 1980 | Supplement 120Labeling | Approved | None posted |
| Jan 21, 1980 | Supplement 119Labeling | Approved | None posted |
| Jan 21, 1980 | Supplement 118Labeling | Approved | None posted |
| Jan 21, 1980 | Supplement 117Labeling | Approved | None posted |
| Jan 21, 1980 | Supplement 116Labeling | Approved | None posted |
| Jan 21, 1980 | Supplement 115Labeling | Approved | None posted |
| Jan 21, 1980 | Supplement 114Labeling | Approved | None posted |
| Jan 21, 1980 | Supplement 113Labeling | Approved | None posted |
| Aug 13, 1979 | Supplement 111Labeling | Approved | None posted |
| Aug 13, 1979 | Supplement 110Labeling | Approved | None posted |
| Aug 13, 1979 | Supplement 109Labeling | Approved | None posted |
| Aug 13, 1979 | Supplement 108Labeling | Approved | None posted |
| Aug 13, 1979 | Supplement 107Labeling | Approved | None posted |
| Aug 13, 1979 | Supplement 106Labeling | Approved | None posted |
| Aug 13, 1979 | Supplement 105Labeling | Approved | None posted |
| Aug 7, 1978 | Supplement 104Labeling | Approved | None posted |
| Jul 31, 1978 | Supplement 103Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 102Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 101Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 100Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 99Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 98Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 97Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 96Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 95Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 94Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 93Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 92Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 91Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 90Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 89Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 88Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 27Labeling | Approved | None posted |
| Jul 31, 1978 | Supplement 87Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 86Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 85Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 84Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 83Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 82Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 81Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 80Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 79Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 78Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 77Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 76Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 75Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 74Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 73Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 72Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 71Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 70Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 69Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 68Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 67Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 66Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 65Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 64Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 63Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 62Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 61Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1978 | Supplement 60Labeling | Approved | None posted |
| Jul 31, 1978 | Supplement 59Labeling | Approved | None posted |
| Jul 31, 1978 | Supplement 58Labeling | Approved | None posted |
| Jul 31, 1978 | Supplement 57Labeling | Approved | None posted |
| Jul 31, 1978 | Supplement 56Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 15Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 16Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 17Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 18Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 19Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 20Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 21Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 22Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 23Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 25Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 26Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 28Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 29Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 30Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 31Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 32Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 33Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 34Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 35Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 36Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 37Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 38Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 39Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 40Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 41Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 42Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 43Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 46Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 47Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 48Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 54Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 53Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 52Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 51Labeling | Approved | None posted |
| Oct 4, 1976 | Supplement 50Labeling | Approved | None posted |
| Jan 22, 1976 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| Mar 26, 1975 | Supplement 11Labeling | Approved | None posted |
| Mar 26, 1975 | Supplement 12Labeling | Approved | None posted |
| Mar 26, 1975 | Supplement 13Labeling | Approved | None posted |
| Apr 29, 1974 | Original applicationNew formulation or manufacturer · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
