Details for New Drug Application (NDA): 203375
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NDA 203375 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, Padagis Us, Pharm Assoc, Rhodes Pharms, Taro, and Wes Pharma Inc, and is included in ten NDAs. It is available from twelve 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. Twelve 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. Twelve 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: 203375
| 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 | 203375 | ANDA | Acella Pharmaceuticals, LLC | 42192-607 | 42192-607-04 | 118 mL in 1 BOTTLE, PLASTIC (42192-607-04) |
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride | SYRUP;ORAL | 203375 | ANDA | Acella Pharmaceuticals, LLC | 42192-607 | 42192-607-16 | 473 mL in 1 BOTTLE, PLASTIC (42192-607-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 2MG/5ML;10MG/5ML;30MG/5ML | ||||
| Approval Date: | Sep 20, 2016 | TE: | AA | RLD: | No | ||||
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