Details for New Drug Application (NDA): 213663
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NDA 213663 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 213663
| Tradename: | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE |
| Applicant: | Granules |
| Ingredient: | diphenhydramine hydrochloride; naproxen sodium |
| Patents: | 0 |
Pharmacology for NDA: 213663
| Mechanism of Action | Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 213663
| 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 | 213663 | ANDA | WALGREEN CO. | 0363-9766 | 0363-9766-08 | 80 TABLET, FILM COATED in 1 BOTTLE (0363-9766-08) |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride; naproxen sodium | TABLET;ORAL | 213663 | ANDA | TARGET CORPORATION | 11673-819 | 11673-819-08 | 80 TABLET in 1 BOTTLE (11673-819-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 25MG;220MG | ||||
| Approval Date: | Sep 24, 2020 | TE: | RLD: | No | |||||
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