Details for New Drug Application (NDA): 209726
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NDA 209726 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 seventeen 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 is one drug master file entry for this compound. Eighteen 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 is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; naproxen sodium profile page.
Summary for 209726
| Tradename: | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE |
| Applicant: | Amneal Pharms Co |
| Ingredient: | diphenhydramine hydrochloride; naproxen sodium |
| Patents: | 0 |
Pharmacology for NDA: 209726
| Mechanism of Action | Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 209726
| 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 | 209726 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1422 | 69238-1422-2 | 1 BOTTLE in 1 CARTON (69238-1422-2) / 20 TABLET, FILM COATED in 1 BOTTLE |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride; naproxen sodium | TABLET;ORAL | 209726 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1422 | 69238-1422-4 | 1 BOTTLE in 1 CARTON (69238-1422-4) / 40 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG;220MG | ||||
| Approval Date: | Oct 23, 2018 | TE: | RLD: | No | |||||
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