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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 015197

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AMICAR (AMINOCAPROIC ACID)
500MG
Marketing Status: Discontinued
Active Ingredient: AMINOCAPROIC ACID
Proprietary Name: AMICAR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N015197
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
AMICAR (AMINOCAPROIC ACID)
1GM
Marketing Status: Discontinued
Active Ingredient: AMINOCAPROIC ACID
Proprietary Name: AMICAR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1GM
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N015197
Product Number: 002
Approval Date: Jun 24, 2004
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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