Physiological Effect: Central Nervous System Depression
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Drugs with Physiological Effect: Central Nervous System Depression
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | AMBIEN | zolpidem tartrate | TABLET;ORAL | 019908-001 | Dec 16, 1992 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | AMBIEN | zolpidem tartrate | TABLET;ORAL | 019908-002 | Dec 16, 1992 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-002 | Sep 2, 2005 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-001 | Sep 2, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-001 | Mar 13, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-001 | Mar 13, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
