Details for New Drug Application (NDA): 090575
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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 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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