Details for New Drug Application (NDA): 018708
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NDA 018708 describes DORAL, which is a drug marketed by Galt Pharms and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the DORAL profile page.
The generic ingredient in DORAL is quazepam. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the quazepam profile page.
The generic ingredient in DORAL is quazepam. There are two drug master file entries for this compound. Two suppliers are 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.
Pharmacology for NDA: 018708
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 | Galt Pharmaceuticals, LLC | 61825-165 | 61825-165-30 | 30 TABLET in 1 BOTTLE (61825-165-30) |
| 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: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-003 | Feb 26, 1987 | ⤷ Try a Trial | ⤷ Try a Trial |
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-003 | Feb 26, 1987 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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