Details for New Drug Application (NDA): 021076
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NDA 021076 describes ALEVE-D SINUS & COLD, which is a drug marketed by Bayer and is included in one NDA. Additional details are available on the ALEVE-D SINUS & COLD profile page.
The generic ingredient in ALEVE-D SINUS & COLD is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
The generic ingredient in ALEVE-D SINUS & COLD is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 021076
| Tradename: | ALEVE-D SINUS & COLD |
| Applicant: | Bayer |
| Ingredient: | naproxen sodium; pseudoephedrine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 220MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 29, 1999 | TE: | RLD: | Yes | |||||
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