Details for New Drug Application (NDA): 011265
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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 011265
Tradename: | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
Applicant: | Ani Pharms |
Ingredient: | dextromethorphan hydrobromide; promethazine hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 011265
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 | 011265 | NDA AUTHORIZED GENERIC | ANI Pharmaceuticals, Inc. | 62559-758 | 62559-758-04 | 118 mL in 1 BOTTLE (62559-758-04) |
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | dextromethorphan hydrobromide; promethazine hydrochloride | SYRUP;ORAL | 011265 | NDA AUTHORIZED GENERIC | ANI Pharmaceuticals, Inc. | 62559-758 | 62559-758-16 | 473 mL in 1 BOTTLE (62559-758-16) |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Apr 2, 1984 | TE: | AA | RLD: | Yes |
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