NDA 50533, held by Pfizer. Doxycycline Hyclate.
As of Nov 13, 2026, NDA 50533 (Vibra-Tabs), held by Pfizer, was first approved by FDA on Jan 15, 1980, with 43 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 15, 1992 | Supplement 27Efficacy (new indication or use) | Approved | None posted |
| Feb 13, 1984 | Supplement 24Efficacy (new indication or use) | Approved | None posted |
| Jan 17, 1984 | Supplement 23Efficacy (new indication or use) | Approved | None posted |
| Jan 15, 1980 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vibra-TabsEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Doxycycline Hyclate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 8, 2025 | Supplement 51Labeling · Standard review | Approved | |
| Mar 31, 2025 | Supplement 50Labeling · Standard review | Approved | |
| Dec 20, 2019 | Supplement 47Labeling · Standard review | Approved | |
| Dec 3, 2018 | Supplement 46Labeling · Standard review | Approved | |
| Jul 26, 2017 | Supplement 45Labeling · Standard review | Approved | |
| Dec 21, 2016 | Supplement 44Labeling · Standard review | Approved | |
| Mar 31, 2016 | Supplement 43Labeling · Standard review | Approved | |
| Sep 12, 2014 | Supplement 42Labeling · Standard review | Approved | |
| Sep 4, 2013 | Supplement 41Labeling · Standard review | Approved | |
| Apr 29, 2013 | Supplement 40Labeling · Standard review | Approved | |
| May 11, 2011 | Supplement 38Labeling · Standard review | Approved | |
| Feb 6, 2008 | Supplement 36Labeling · Standard review | Approved | |
| Mar 12, 2004 | Supplement 32Labeling · Standard review | Approved | |
| Jun 18, 2002 | Supplement 30Labeling · Standard review | Approved | |
| May 15, 2002 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Mar 6, 2000 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| May 8, 1998 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Dec 15, 1992 | Supplement 27Efficacy (new indication or use) | Approved | None posted |
| May 11, 1992 | Supplement 26Labeling | Approved | None posted |
| May 7, 1992 | Supplement 11Labeling | Approved | None posted |
| Aug 23, 1991 | Supplement 9Labeling | Approved | None posted |
| Jul 24, 1991 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 22, 1984 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Feb 13, 1984 | Supplement 24Efficacy (new indication or use) | Approved | None posted |
| Jan 17, 1984 | Supplement 23Efficacy (new indication or use) | Approved | None posted |
| Nov 21, 1983 | Supplement 21Labeling | Approved | None posted |
| Apr 1, 1983 | Supplement 20Labeling | Approved | None posted |
| Aug 31, 1982 | Supplement 19Labeling | Approved | None posted |
| Apr 2, 1982 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1982 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1982 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Dec 17, 1981 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Dec 15, 1981 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jun 30, 1981 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Apr 2, 1981 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Mar 11, 1981 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Feb 26, 1981 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 5, 1981 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Oct 21, 1980 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Aug 12, 1980 | Supplement 5Labeling | Approved | None posted |
| Jul 25, 1980 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Apr 1, 1980 | Supplement 2Labeling | Approved | None posted |
| Jan 21, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 15, 1980 | Original applicationNew dosage form · Standard 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
