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Details for New Drug Application (NDA): 021774
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The generic ingredient in AMBIEN CR is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 021774
Tradename: | AMBIEN CR |
Applicant: | Sanofi Aventis Us |
Ingredient: | zolpidem tartrate |
Patents: | 1 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021774
Mechanism of Action | GABA A Agonists |
Physiological Effect | Central Nervous System Depression |
Suppliers and Packaging for NDA: 021774
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774 | NDA | Sanofi-Aventis U.S. LLC | 0024-5501 | 0024-5501-31 | 100 TABLET, COATED in 1 BOTTLE (0024-5501-31) |
AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774 | NDA | Sanofi-Aventis U.S. LLC | 0024-5521 | 0024-5521-31 | 100 TABLET, COATED in 1 BOTTLE (0024-5521-31) |
Paragraph IV (Patent) Challenges for 021774
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
AMBIEN CR | TABLET, EXTENDED RELEASE;ORAL | zolpidem tartrate | 021774 | 2006-02-24 |
AMBIEN CR | TABLET, EXTENDED RELEASE;ORAL | zolpidem tartrate | 021774 | 2006-01-19 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 12.5MG | ||||
Approval Date: | Sep 2, 2005 | TE: | AB | RLD: | Yes | ||||
Patent: | Start Trial | Patent Expiration: | Jun 1, 2020 | Product Flag? | Substance Flag? | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 6.25MG | ||||
Approval Date: | Sep 2, 2005 | TE: | AB | RLD: | Yes | ||||
Patent: | Start Trial | Patent Expiration: | Jun 1, 2020 | Product Flag? | Substance Flag? | Delist Request? |
Expired US Patents for NDA 021774
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-002 | Sep 2, 2005 | Start Trial | Start Trial |
Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-002 | Sep 2, 2005 | Start Trial | Start Trial |
Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-001 | Sep 2, 2005 | Start Trial | Start Trial |
Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-001 | Sep 2, 2005 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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