Details for New Drug Application (NDA): 205352
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NDA 205352 describes ALEVE PM, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the ALEVE PM profile page.
The generic ingredient in ALEVE PM is diphenhydramine hydrochloride; naproxen sodium. There are twenty-three drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; naproxen sodium profile page.
The generic ingredient in ALEVE PM is diphenhydramine hydrochloride; naproxen sodium. There are twenty-three drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; naproxen sodium profile page.
Summary for 205352
| Tradename: | ALEVE PM |
| Applicant: | Bayer Hlthcare |
| Ingredient: | diphenhydramine hydrochloride; naproxen sodium |
| Patents: | 0 |
Pharmacology for NDA: 205352
| Mechanism of Action | Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 205352
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALEVE PM | diphenhydramine hydrochloride; naproxen sodium | TABLET;ORAL | 205352 | NDA | Bayer HealthCare LLC. | 0280-1200 | 0280-1200-01 | 1 BOTTLE in 1 CARTON (0280-1200-01) / 120 TABLET, FILM COATED in 1 BOTTLE |
| ALEVE PM | diphenhydramine hydrochloride; naproxen sodium | TABLET;ORAL | 205352 | NDA | Bayer HealthCare LLC. | 0280-1200 | 0280-1200-02 | 2 TABLET, FILM COATED in 1 POUCH (0280-1200-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 25MG;220MG | ||||
| Approval Date: | Jan 17, 2014 | TE: | RLD: | Yes | |||||
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