Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076383

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NIZATIDINE (NIZATIDINE)
150MG
Marketing Status: Discontinued

Active Ingredient: NIZATIDINE
Proprietary Name: NIZATIDINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076383
Product Number: 001
Approval Date: Jan 23, 2003
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

NIZATIDINE (NIZATIDINE)
300MG
Marketing Status: Discontinued

Active Ingredient: NIZATIDINE
Proprietary Name: NIZATIDINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076383
Product Number: 002
Approval Date: Jan 23, 2003
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Discontinued
Patent and Exclusivity Information