Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 070920

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TEMAZEPAM (TEMAZEPAM)
7.5MG
Marketing Status: Discontinued

Active Ingredient: TEMAZEPAM
Proprietary Name: TEMAZEPAM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A070920
Product Number: 002
Approval Date: May 21, 2010
Applicant Holder Full Name: AUROBINDO PHARMA USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

TEMAZEPAM (TEMAZEPAM)
15MG
Marketing Status: Discontinued

Active Ingredient: TEMAZEPAM
Proprietary Name: TEMAZEPAM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A070920
Product Number: 004
Approval Date: Jul 7, 1986
Applicant Holder Full Name: AUROBINDO PHARMA USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

TEMAZEPAM (TEMAZEPAM)
22.5MG
Marketing Status: Discontinued

Active Ingredient: TEMAZEPAM
Proprietary Name: TEMAZEPAM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 22.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A070920
Product Number: 003
Approval Date: Jun 12, 2009
Applicant Holder Full Name: AUROBINDO PHARMA USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

TEMAZEPAM (TEMAZEPAM)
30MG
Marketing Status: Discontinued

Active Ingredient: TEMAZEPAM
Proprietary Name: TEMAZEPAM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A070920
Product Number: 001
Approval Date: Jul 10, 1986
Applicant Holder Full Name: AUROBINDO PHARMA USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information