PROMETHAZINE HYDROCHLORIDE | N008381 | ANI PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Public Citizen Health Research Group FDA-1976-N-0519 Public Citizen Health Research Group and the University of Maryland Sudden Infant Death Syndrome Institute filed this petition requesting that the FDA immediately ban all over-the-counter use of promethazine hydrochloride products including Phenergan DM and Phenergan VC, contraindicate prescription | Other | 2011-03-25 | Granted | Public Citizen Health Research Group |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2009-P-0249 Lachman Consultant Services, Inc. filed this petition on May 26, 2009 pursuant to Section 505(j)(2)(C) requesting that the FDA declare Promethazine Hydrochloride Effervescent Tablets in 25 mg and 50 mg strengths suitable for submission as an ANDA, with the reference-listed drug being Sandoz's Promet | Other | 2009-05-29 | Withdrawn | — |
Citizen Petition from Taro Pharmaceuticals USA, Inc. FDA-2006-P-0005 Taro Pharmaceuticals USA, Inc. filed this citizen petition on October 31, 2006, requesting that the FDA make a determination of ANDA suitability for Promethazine Hydrochloride Suppositories USP in 12.5 mg and 25 mg strengths, which were voluntarily withdrawn from sale by Wyeth for reasons other than | Other | 2008-08-12 | Open | Taro Pharmaceuticals USA, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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