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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021618

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TINDAMAX (TINIDAZOLE)
250MG
Marketing Status: Prescription
Active Ingredient: TINIDAZOLE
Proprietary Name: TINDAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021618
Product Number: 001
Approval Date: May 17, 2004
Applicant Holder Full Name: MISSION PHARMACAL CO
Marketing Status:  Prescription
Patent and Exclusivity Information
TINDAMAX (TINIDAZOLE)
500MG
Marketing Status: Prescription
Active Ingredient: TINIDAZOLE
Proprietary Name: TINDAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021618
Product Number: 002
Approval Date: May 17, 2004
Applicant Holder Full Name: MISSION PHARMACAL CO
Marketing Status:  Prescription
Patent and Exclusivity Information
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