Details for New Drug Application (NDA): 090575
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NDA 090575 describes PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Cosette, and Hikma, and is included in four NDAs. It is available from seven 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.
Summary for 090575
| Tradename: | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
| Applicant: | Amneal Pharms |
| Ingredient: | dextromethorphan hydrobromide; promethazine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 090575
| Mechanism of Action | Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists |
Suppliers and Packaging for NDA: 090575
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 090575 | ANDA | Amneal Pharmaceuticals LLC | 65162-680 | 65162-680-86 | 118 mL in 1 BOTTLE (65162-680-86) |
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 090575 | ANDA | Amneal Pharmaceuticals LLC | 65162-680 | 65162-680-90 | 473 mL in 1 BOTTLE (65162-680-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 15MG/5ML;6.25MG/5ML | ||||
| Approval Date: | Feb 8, 2011 | TE: | AA | RLD: | No | ||||
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