Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019593

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ZANTAC IN PLASTIC CONTAINER (RANITIDINE HYDROCHLORIDE)
EQ 1MG BASE/ML
Marketing Status: Discontinued

Active Ingredient: RANITIDINE HYDROCHLORIDE
Proprietary Name: ZANTAC IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019593
Product Number: 002
Approval Date: Sep 27, 1991
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ZANTAC IN PLASTIC CONTAINER (RANITIDINE HYDROCHLORIDE)
EQ 50MG BASE/100ML
Marketing Status: Discontinued

Active Ingredient: RANITIDINE HYDROCHLORIDE
Proprietary Name: ZANTAC IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 50MG BASE/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019593
Product Number: 001
Approval Date: Dec 17, 1986
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information