Bromodiphenhydramine Hydrochloride And Codeine Phosphate

ANDA 88626, held by Wockhardt. Bromodiphenhydramine Hydrochloride; Codeine Phosphate.

As of Nov 15, 2026, ANDA 88626 (Bromodiphenhydramine Hydrochloride And Codeine Phosphate), held by Wockhardt, was first approved by FDA on Oct 12, 1984, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 12, 1984
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Oct 12, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bromodiphenhydramine Hydrochloride And Codeine Phosphate12.5MG/5ML;10MG/5ML · syrup;oral	Bromodiphenhydramine Hydrochloride; Codeine Phosphate	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Jan 11, 1994	Supplement 12Labeling	Approved	None posted
Jan 15, 1991	Supplement 11Labeling	Approved	None posted
Aug 16, 1988	Supplement 9Manufacturing	Approved	None posted
Apr 7, 1987	Supplement 6Manufacturing	Approved	None posted
Aug 8, 1986	Supplement 5Manufacturing	Approved	None posted
Oct 16, 1985	Supplement 2Manufacturing	Approved	None posted
Oct 16, 1985	Supplement 1Manufacturing	Approved	None posted
Oct 12, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88626
Drugs@FDA: Overview at FDA
Company: Wockhardt

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