TEMAZEPAM | A070384 | WATSON LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Daniel F. Kripke, MD (The Weston Firm) FDA-2015-P-3959 · 6 docket documents Dr. Daniel F. Kripke filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA take multiple administrative actions regarding hypnotic drugs including zolpidem, temazepam, eszopiclone, zaleplon, triazolam, flurazepam, quazepam, and barbiturates such as pentobarbital, amobarbital, a | Other | 2015-12-16 | Open | Daniel F. Kripke, MD (The Weston Firm) |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2006-P-0396 · 7 docket documents Lachman Consultant Services, Inc., on behalf of a client, filed this citizen petition under Section 505(j)(2)(C) requesting FDA approval to submit an Abbreviated New Drug Application for Temazepam Orally Disintegrating Tablets in strengths of 7.5 mg, 15 mg, 22.5 mg, and 30 mg, with Restoril (temazep | Other | 2015-09-29 | Withdrawn | Lachman Consultant Services, Inc. |
Mallinckrodt, Inc. Tyco Healthcare Group LP (Hyman, Phelps & McNamara, P.C.) ... FDA-2009-P-0379 · 9 docket documents Mallinckrodt, Inc. and Tyco Healthcare Group LP filed this citizen petition pursuant to 21 C.F.R. § 10.30 requesting that FDA withdraw and revise its April 2009 draft guidance on temazepam bioequivalence to require ANDA applicants to demonstrate additional bioequivalence criteria including partial a | 505(q) | 2009-08-19 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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