Details for New Drug Application (NDA): 203997
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NDA 203997 describes BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Acella, Alkem Labs Ltd, Bionpharma, Chartwell Molecular, Dr Reddys Labs Sa, Hibrow Hlthcare, Padagis Us, Pharm Assoc, Rhodes Pharms, and Taro, and is included in ten NDAs. It is available from thirteen suppliers. Additional details are available on the BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE profile page.
The generic ingredient in BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride. There are twenty-one drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride profile page.
The generic ingredient in BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride. There are twenty-one drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride profile page.
Suppliers and Packaging for NDA: 203997
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride | SYRUP;ORAL | 203997 | ANDA | BIONPHARMA INC. | 69452-478 | 69452-478-55 | 118 mL in 1 BOTTLE (69452-478-55) |
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride | SYRUP;ORAL | 203997 | ANDA | BIONPHARMA INC. | 69452-478 | 69452-478-88 | 473 mL in 1 BOTTLE (69452-478-88) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 2MG/5ML;10MG/5ML;30MG/5ML | ||||
| Approval Date: | Sep 30, 2020 | TE: | AA | RLD: | No | ||||
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