Details for New Drug Application (NDA): 040027
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NDA 040027 describes PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Hikma, and Tris Pharma Inc, and is included in four NDAs. It is available from five suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE profile page.
The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.
The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.
Summary for 040027
| Tradename: | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
| Applicant: | Hikma |
| Ingredient: | dextromethorphan hydrobromide; promethazine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 15MG/5ML;6.25MG/5ML | ||||
| Approval Date: | Jul 31, 1996 | TE: | RLD: | No | |||||
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