Details for New Drug Application (NDA): 019908
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The generic ingredient in AMBIEN is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 019908
Tradename: | AMBIEN |
Applicant: | Sanofi Aventis Us |
Ingredient: | zolpidem tartrate |
Patents: | 0 |
Pharmacology for NDA: 019908
Mechanism of Action | GABA A Receptor Positive Modulators |
Physiological Effect | Central Nervous System Depression |
Suppliers and Packaging for NDA: 019908
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMBIEN | zolpidem tartrate | TABLET;ORAL | 019908 | NDA | Sanofi-Aventis U.S. LLC | 0024-5401 | 0024-5401-31 | 100 TABLET, FILM COATED in 1 BOTTLE (0024-5401-31) |
AMBIEN | zolpidem tartrate | TABLET;ORAL | 019908 | NDA | Sanofi-Aventis U.S. LLC | 0024-5421 | 0024-5421-31 | 100 TABLET, FILM COATED in 1 BOTTLE (0024-5421-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 16, 1992 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 16, 1992 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 019908
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sanofi Aventis Us | AMBIEN | zolpidem tartrate | TABLET;ORAL | 019908-001 | Dec 16, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | AMBIEN | zolpidem tartrate | TABLET;ORAL | 019908-002 | Dec 16, 1992 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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