Bromodiphenhydramine hydrochloride - Generic Drug Details
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What are the generic drug sources for bromodiphenhydramine hydrochloride and what is the scope of patent protection?
Bromodiphenhydramine hydrochloride
is the generic ingredient in four branded drugs marketed by Parke Davis, Forest Labs, Alpharma Us Pharms, and Wockhardt, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.There is one drug master file entry for bromodiphenhydramine hydrochloride.
Summary for bromodiphenhydramine hydrochloride
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 4 |
| NDAs: | 4 |
| Drug Master File Entries: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 40 |
| Patent Applications: | 136 |
| DailyMed Link: | bromodiphenhydramine hydrochloride at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for bromodiphenhydramine hydrochloride
US Patents and Regulatory Information for bromodiphenhydramine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Parke Davis | AMBODRYL | bromodiphenhydramine hydrochloride | CAPSULE;ORAL | 007984-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alpharma Us Pharms | BROMANYL | bromodiphenhydramine hydrochloride; codeine phosphate | SYRUP;ORAL | 088343-001 | Aug 15, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Wockhardt | BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE | bromodiphenhydramine hydrochloride; codeine phosphate | SYRUP;ORAL | 088626-001 | Oct 12, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Forest Labs | AMBENYL | bromodiphenhydramine hydrochloride; codeine phosphate | SYRUP;ORAL | 009319-006 | Jan 10, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
