Details for New Drug Application (NDA): 019279
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NDA 019279 describes DIMETANE-DX, which is a drug marketed by Robins Ah and is included in one NDA. Additional details are available on the DIMETANE-DX profile page.
The generic ingredient in DIMETANE-DX 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 DIMETANE-DX 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 019279
| Tradename: | DIMETANE-DX |
| Applicant: | Robins Ah |
| Ingredient: | brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 2MG/5ML;10MG/5ML;30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 24, 1984 | TE: | RLD: | Yes | |||||
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