Product Details for NDA 018163
RESTORIL (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: RESTORIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 7.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018163
Product Number: 003
Approval Date: Oct 25, 1991
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
RESTORIL (TEMAZEPAM)
Proprietary Name: RESTORIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 7.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018163
Product Number: 003
Approval Date: Oct 25, 1991
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
15MG
Marketing Status: Prescription
Active Ingredient: TEMAZEPAM
Proprietary Name: RESTORIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018163
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
RESTORIL (TEMAZEPAM)
Proprietary Name: RESTORIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018163
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
22.5MG
Marketing Status: Prescription
Active Ingredient: TEMAZEPAM
Proprietary Name: RESTORIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 22.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018163
Product Number: 004
Approval Date: Nov 2, 2004
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
RESTORIL (TEMAZEPAM)
Proprietary Name: RESTORIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 22.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018163
Product Number: 004
Approval Date: Nov 2, 2004
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
30MG
Marketing Status: Prescription
Active Ingredient: TEMAZEPAM
Proprietary Name: RESTORIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N018163
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: RESTORIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N018163
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information