Details for New Drug Application (NDA): 021920
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The generic ingredient in NAPROXEN SODIUM is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 021920
Tradename: | NAPROXEN SODIUM |
Applicant: | Bionpharma |
Ingredient: | naproxen sodium |
Patents: | 5 |
Pharmacology for NDA: 021920
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 021920
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPROXEN SODIUM | naproxen sodium | CAPSULE;ORAL | 021920 | NDA | Bayer HealthCare LLC. | 0280-6080 | 0280-6080-01 | 1 BOTTLE in 1 CARTON (0280-6080-01) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE |
NAPROXEN SODIUM | naproxen sodium | CAPSULE;ORAL | 021920 | NDA | Bayer HealthCare LLC. | 0280-6080 | 0280-6080-02 | 2 BOTTLE in 1 PACKAGE, COMBINATION (0280-6080-02) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
Approval Date: | Feb 17, 2006 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 3, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TEMPORARY REDUCTION OF FEVER | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 3, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TEMPORARY RELIEF OF MINOR ACHES AND PAINS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 3, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TEMPORARY REDUCTION OF FEVER |
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