Details for New Drug Application (NDA): 020204
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NDA 020204 describes ALEVE, which is a drug marketed by Bayer and Bayer Hlthcare and is included in three NDAs. It is available from eight suppliers. Additional details are available on the ALEVE profile page.
The generic ingredient in ALEVE 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 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 020204
| Tradename: | ALEVE |
| Applicant: | Bayer |
| Ingredient: | naproxen sodium |
| Patents: | 0 |
Pharmacology for NDA: 020204
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 020204
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALEVE | naproxen sodium | TABLET;ORAL | 020204 | NDA | Bayer HealthCare LLC | 0280-0041 | 0280-0041-01 | 1 BOTTLE in 1 CARTON (0280-0041-01) / 175 TABLET in 1 BOTTLE |
| ALEVE | naproxen sodium | TABLET;ORAL | 020204 | NDA | Bayer HealthCare LLC | 0280-0041 | 0280-0041-02 | 1 BOTTLE in 1 CARTON (0280-0041-02) / 50 TABLET in 1 BOTTLE |
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 220MG | ||||
| Approval Date: | Jan 11, 1994 | TE: | RLD: | Yes | |||||
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