Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020353

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NAPRELAN (NAPROXEN SODIUM)
EQ 375MG BASE
Marketing Status: Prescription

Active Ingredient: NAPROXEN SODIUM
Proprietary Name: NAPRELAN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 375MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020353
Product Number: 001
Approval Date: Jan 5, 1996
Applicant Holder Full Name: TWI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NAPRELAN (NAPROXEN SODIUM)
EQ 500MG BASE
Marketing Status: Prescription

Active Ingredient: NAPROXEN SODIUM
Proprietary Name: NAPRELAN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 500MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020353
Product Number: 002
Approval Date: Jan 5, 1996
Applicant Holder Full Name: TWI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NAPRELAN (NAPROXEN SODIUM)
EQ 750MG BASE
Marketing Status: Prescription

Active Ingredient: NAPROXEN SODIUM
Proprietary Name: NAPRELAN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 750MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020353
Product Number: 003
Approval Date: Jan 5, 1996
Applicant Holder Full Name: TWI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information