NDA 13055, held by Pai Holdings Pharm. Orphenadrine Citrate.
As of Nov 13, 2026, NDA 13055 (Norflex), held by Pai Holdings Pharm, was first approved by FDA on Oct 2, 1960, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 2, 1960 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Norflex30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Orphenadrine Citrate | DiscontinuedReference drug |
| Feb 11, 2008 | Supplement 21Labeling · Standard review | Approved | |
| Jun 4, 2002 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Jun 6, 2001 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Nov 22, 2000 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Sep 24, 1992 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Sep 3, 1991 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Aug 22, 1985 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Nov 29, 1978 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Mar 24, 1978 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Nov 3, 1975 | Supplement 8Labeling | Approved | None posted |
| Oct 2, 1960 | Original applicationNew dosage form · 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
