Details for New Drug Application (NDA): 208499
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NDA 208499 describes NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms Co, Corepharma, Granules, P And L, and Perrigo R And D, and is included in five NDAs. It is available from twenty-one suppliers. Additional details are available on the NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE profile page.
The generic ingredient in NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 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 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE 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 208499
| Tradename: | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE |
| Applicant: | Perrigo R And D |
| Ingredient: | diphenhydramine hydrochloride; naproxen sodium |
| Patents: | 0 |
Pharmacology for NDA: 208499
| Mechanism of Action | Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 208499
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride; naproxen sodium | TABLET;ORAL | 208499 | ANDA | L. Perrigo Company | 0113-8264 | 0113-8264-60 | 1 BOTTLE in 1 CARTON (0113-8264-60) / 20 TABLET, FILM COATED in 1 BOTTLE |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride; naproxen sodium | TABLET;ORAL | 208499 | ANDA | L. Perrigo Company | 0113-8264 | 0113-8264-71 | 1 BOTTLE in 1 CARTON (0113-8264-71) / 50 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 25MG;220MG | ||||
| Approval Date: | May 10, 2019 | TE: | RLD: | No | |||||
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