Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017581

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NAPROSYN (NAPROXEN)
500MG
Marketing Status: Prescription

Active Ingredient: NAPROXEN
Proprietary Name: NAPROSYN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N017581
Product Number: 004
Approval Date: Apr 15, 1982
Applicant Holder Full Name: ATNAHS PHARMA US LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

NAPROSYN (NAPROXEN)
250MG
Marketing Status: Discontinued

Active Ingredient: NAPROXEN
Proprietary Name: NAPROSYN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N017581
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ATNAHS PHARMA US LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

NAPROSYN (NAPROXEN)
375MG
Marketing Status: Discontinued

Active Ingredient: NAPROXEN
Proprietary Name: NAPROSYN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 375MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N017581
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ATNAHS PHARMA US LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information