FDA Orange Book · active-ingredient family
Bromodiphenhydramine hydrochloride; codeine phosphate
Bromodiphenhydramine hydrochloride; codeine phosphate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AMBENYL · NDA 009319
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · syrup
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMBENYL | FOREST LABS | NDA 009319 | — | Jan 10, 1984 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE | WOCKHARDT | ANDA 088626 | — | Oct 12, 1984 | |
| BROMANYL | ALPHARMA US PHARMS | ANDA 088343 | — | Aug 15, 1984 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Bromodiphenhydramine hydrochloride; codeine phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
