Details for New Drug Application (NDA): 088811
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NDA 088811 describes BROMFED-DM, which is a drug marketed by Wockhardt and Wockhardt Bio Ag and is included in two NDAs. It is available from one supplier. Additional details are available on the BROMFED-DM profile page.
The generic ingredient in BROMFED-DM 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 BROMFED-DM 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.
Summary for 088811
| Tradename: | BROMFED-DM |
| Applicant: | Wockhardt Bio Ag |
| Ingredient: | brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 088811
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BROMFED-DM | brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride | SYRUP;ORAL | 088811 | ANDA | Proficient Rx LP | 63187-400 | 63187-400-04 | 118 mL in 1 BOTTLE, PLASTIC (63187-400-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 2MG/5ML;10MG/5ML;30MG/5ML | ||||
| Approval Date: | Jun 7, 1985 | TE: | AA | RLD: | Yes | ||||
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