ANDA 75153, held by L Perrigo Co. Pseudoephedrine Hydrochloride.
As of Nov 15, 2026, ANDA 75153 (Pseudoephedrine Hydrochloride), held by L Perrigo Co, was first approved by FDA on Feb 26, 1999, with 10 approved supplements and 0 published complete response letters.
Uses
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 26, 1999 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pseudoephedrine Hydrochloride120MG · tablet, extended release;oral | Pseudoephedrine Hydrochloride | OTC |
| May 24, 2011 | Supplement 34Labeling | Approved | None posted |
| Apr 20, 2005 | Supplement 17Labeling | Approved | None posted |
| Dec 9, 2002 | Supplement 9Manufacturing | Approved | None posted |
| May 7, 2002 | Supplement 5Manufacturing | Approved | None posted |
| May 7, 2002 | Supplement 6Manufacturing | Approved | None posted |
| Dec 12, 2001 | Supplement 8Labeling | Approved | None posted |
| Oct 22, 2001 | Supplement 7Manufacturing | Approved | None posted |
| Apr 17, 2001 | Supplement 3Manufacturing | Approved | None posted |
| Apr 17, 2001 | Supplement 4Manufacturing | Approved | None posted |
| Feb 28, 2000 | Supplement 1Manufacturing | Approved | None posted |
| Feb 26, 1999 | Original application | Approved |
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
