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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040090

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ISONIAZID (ISONIAZID)
100MG
Marketing Status: Prescription
Active Ingredient: ISONIAZID
Proprietary Name: ISONIAZID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A040090
Product Number: 001
Approval Date: Jun 26, 1997
Applicant Holder Full Name: OMNIVIUM PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
ISONIAZID (ISONIAZID)
300MG
Marketing Status: Prescription
Active Ingredient: ISONIAZID
Proprietary Name: ISONIAZID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A040090
Product Number: 002
Approval Date: Jun 26, 1997
Applicant Holder Full Name: OMNIVIUM PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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