Product Details for ANDA 203482
TEMAZEPAM (TEMAZEPAM)
7.5MG
Marketing Status: Prescription
15MG
Marketing Status: Prescription
22.5MG
Marketing Status: Prescription
30MG
Marketing Status: Prescription
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: A203482
Product Number: 001
Approval Date: May 23, 2016
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS
Marketing Status: Prescription
Patent and Exclusivity Information
TEMAZEPAM (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: A203482
Product Number: 001
Approval Date: May 23, 2016
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS
Marketing Status: Prescription
Patent and Exclusivity Information
15MG
Marketing Status: Prescription
Active Ingredient: TEMAZEPAM
Proprietary Name: TEMAZEPAM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203482
Product Number: 002
Approval Date: May 23, 2016
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS
Marketing Status: Prescription
Patent and Exclusivity Information
TEMAZEPAM (TEMAZEPAM)
Proprietary Name: TEMAZEPAM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203482
Product Number: 002
Approval Date: May 23, 2016
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS
Marketing Status: Prescription
Patent and Exclusivity Information
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: A203482
Product Number: 003
Approval Date: May 23, 2016
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS
Marketing Status: Prescription
Patent and Exclusivity Information
TEMAZEPAM (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: A203482
Product Number: 003
Approval Date: May 23, 2016
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS
Marketing Status: Prescription
Patent and Exclusivity Information
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: A203482
Product Number: 004
Approval Date: May 23, 2016
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: TEMAZEPAM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203482
Product Number: 004
Approval Date: May 23, 2016
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS
Marketing Status: Prescription
Patent and Exclusivity Information