Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 007073

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AZULFIDINE (SULFASALAZINE)
500MG
Marketing Status: Prescription

Active Ingredient: SULFASALAZINE
Proprietary Name: AZULFIDINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N007073
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AZULFIDINE EN-TABS (SULFASALAZINE)
500MG
Marketing Status: Prescription

Active Ingredient: SULFASALAZINE
Proprietary Name: AZULFIDINE EN-TABS
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N007073
Product Number: 002
Approval Date: Apr 6, 1983
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information