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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "018163."



Active Ingredient: TEMAZEPAM
Dosage Form;Route: CAPSULE;ORAL
Proprietary Name: RESTORIL
Applicant: MALLINCKRODT INC
Strength: 15MG
Application Number: N018163
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: TEMAZEPAM
Dosage Form;Route: CAPSULE;ORAL
Proprietary Name: RESTORIL
Applicant: MALLINCKRODT INC
Strength: 30MG
Application Number: N018163
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: TEMAZEPAM
Dosage Form;Route: CAPSULE;ORAL
Proprietary Name: RESTORIL
Applicant: MALLINCKRODT INC
Strength: 7.5MG
Application Number: N018163
Product Number: 003
Approval Date: Oct 25, 1991
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: TEMAZEPAM
Dosage Form;Route: CAPSULE;ORAL
Proprietary Name: RESTORIL
Applicant: MALLINCKRODT INC
Strength: 22.5MG
Application Number: N018163
Product Number: 004
Approval Date: Nov 2, 2004
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through September 2014
Patent and Generic Drug Product Data Last Updated October 20, 2014

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