Details for New Drug Application (NDA): 018163
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The generic ingredient in RESTORIL is temazepam. There are seven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the temazepam profile page.
Summary for 018163
Tradename: | RESTORIL |
Applicant: | Specgx Llc |
Ingredient: | temazepam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 018163
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RESTORIL | temazepam | CAPSULE;ORAL | 018163 | NDA | SpecGx LLC | 0406-9914 | 0406-9914-03 | 30 CAPSULE in 1 BOTTLE (0406-9914-03) |
RESTORIL | temazepam | CAPSULE;ORAL | 018163 | NDA | SpecGx LLC | 0406-9915 | 0406-9915-01 | 100 CAPSULE in 1 BOTTLE (0406-9915-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 15MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 7.5MG | ||||
Approval Date: | Oct 25, 1991 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 018163
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Specgx Llc | RESTORIL | temazepam | CAPSULE;ORAL | 018163-003 | Oct 25, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Specgx Llc | RESTORIL | temazepam | CAPSULE;ORAL | 018163-003 | Oct 25, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Specgx Llc | RESTORIL | temazepam | CAPSULE;ORAL | 018163-003 | Oct 25, 1991 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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