Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 071457

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TEMAZEPAM (TEMAZEPAM)
7.5MG
Marketing Status: Prescription

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: AB
Application Number: A071457
Product Number: 002
Approval Date: Jun 22, 2012
Applicant Holder Full Name: NOVEL LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TEMAZEPAM (TEMAZEPAM)
22.5MG
Marketing Status: Prescription

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: AB
Application Number: A071457
Product Number: 003
Approval Date: Jun 22, 2012
Applicant Holder Full Name: NOVEL LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TEMAZEPAM (TEMAZEPAM)
30MG
Marketing Status: Prescription

Active Ingredient: TEMAZEPAM
Proprietary Name: TEMAZEPAM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A071457
Product Number: 001
Approval Date: Apr 21, 1987
Applicant Holder Full Name: NOVEL LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information