Details for New Drug Application (NDA): 018708
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The generic ingredient in DORAL is quazepam. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the quazepam profile page.
Summary for 018708
Tradename: | DORAL |
Applicant: | Galt Pharms |
Ingredient: | quazepam |
Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 018708
Generic Entry Date for 018708*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 018708
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DORAL | quazepam | TABLET;ORAL | 018708 | NDA AUTHORIZED GENERIC | Atland Pharmaceuticals, LLC | 71993-265 | 71993-265-30 | 30 TABLET in 1 BOTTLE (71993-265-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Dec 27, 1985 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 3, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD FOR TREATING INSOMNIA WHILE REDUCING THE RISK OF AN ADVERSE DRUG INTERACTION |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
Approval Date: | Feb 26, 1987 | TE: | RLD: | No | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 3, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD FOR TREATING INSOMNIA WHILE REDUCING THE RISK OF AN ADVERSE DRUG INTERACTION |
Expired US Patents for NDA 018708
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-003 | Feb 26, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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