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Details for New Drug Application (NDA): 021774
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NDA 021774 describes AMBIEN CR, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from seven suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the AMBIEN CR profile page.
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.
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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