Details for New Drug Application (NDA): 211360
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NDA 211360 describes NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Dr Reddys Labs Inc, and Perrigo, and is included in three NDAs. It is available from nine suppliers. Additional details are available on the NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.
The generic ingredient in NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
The generic ingredient in NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 211360
| Tradename: | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | naproxen sodium; pseudoephedrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 211360
| Mechanism of Action | Adrenergic alpha-Agonists Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 211360
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | naproxen sodium; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211360 | ANDA | Aurohealth LLC | 58602-816 | 58602-816-67 | 2 BLISTER PACK in 1 CARTON (58602-816-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | naproxen sodium; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 211360 | ANDA | Aurohealth LLC | 58602-816 | 58602-816-72 | 3 BLISTER PACK in 1 CARTON (58602-816-72) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 220MG;120MG | ||||
| Approval Date: | Jun 1, 2022 | TE: | RLD: | No | |||||
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