Details for New Drug Application (NDA): 083820
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NDA 083820 describes BROMPHENIRAMINE MALEATE, which is a drug marketed by Alpharma Us Pharms, Kv Pharm, Pharm Assoc, Usl Pharma, Watson Labs, Barr, Ivax Sub Teva Pharms, Newtron Pharms, Nexgen Pharma Inc, Par Pharm, Pioneer Pharms, Upsher Smith Labs, Vitarine, Acella, Alkem Labs Ltd, Bionpharma, Chartwell Molecular, Dr Reddys Labs Sa, Padagis Us, Rhodes Pharms, Taro, and Wes Pharma Inc, and is included in twenty-six NDAs. Additional details are available on the BROMPHENIRAMINE MALEATE profile page.
The generic ingredient in BROMPHENIRAMINE MALEATE 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 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 083820
| Tradename: | BROMPHENIRAMINE MALEATE |
| Applicant: | Watson Labs |
| Ingredient: | brompheniramine maleate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 083820
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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