Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075927

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NAPROXEN (NAPROXEN)
250MG
Marketing Status: Prescription

Active Ingredient: NAPROXEN
Proprietary Name: NAPROXEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075927
Product Number: 001
Approval Date: Dec 18, 2001
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS NY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NAPROXEN (NAPROXEN)
375MG
Marketing Status: Prescription

Active Ingredient: NAPROXEN
Proprietary Name: NAPROXEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 375MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075927
Product Number: 002
Approval Date: Dec 18, 2001
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS NY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NAPROXEN (NAPROXEN)
500MG
Marketing Status: Prescription

Active Ingredient: NAPROXEN
Proprietary Name: NAPROXEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075927
Product Number: 003
Approval Date: Dec 18, 2001
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS NY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information