PENICILLIN G POTASSIUM | A060307 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Center for Food Safety and Institute for Agriculture and Trade Policy - Citiz... FDA-2013-P-0351 · 4 docket documents The Center for Food Safety and Institute for Agriculture and Trade Policy filed this citizen petition on March 15, 2013, requesting that the FDA prohibit the use of antibiotics such as penicillin, virginiamycin, erythromycin, tylosin, and tetracycline in the production of distillers grains sold as a | Other | 2013-04-11 | Denied | — |
AllerQuest LLC - Citizen Petition FDA-2009-P-0297 · 3 docket documents AllerQuest LLC filed this citizen petition on June 23, 2009, requesting that the FDA Commissioner certify that Pre-Pen® was not withdrawn from the US market due to safety or efficacy reasons, as a prerequisite for AllerQuest's planned submission of an ANDA to reintroduce the penicillin allergy skin | Other | 2009-07-02 | Withdrawn | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2008-P-0320 · 5 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA determine whether Pfizer's Pfizerpén (penicillin G potassium) Injection, 1,000,000 units/vial, listed under ANDA 60-857, and Sandoz's Penicillin G Potassium Injection, 1,000,000 units/vial, listed under ANDA 65-079, were v | 505(q) | 2008-06-02 | Granted | — |
Victor L. Yu. M.D. - Citizen Petition FDA-2007-P-0414 · 7 docket documents Victor L. Yu, M.D. filed this citizen petition under Section 505 of the Food, Drug and Cosmetic Act requesting that the FDA Commissioner modify the in vitro breakpoints for penicillin and Streptococcus pneumoniae that were originally established by the Clinical and Laboratory Standards Institute, as | Other | 2008-04-21 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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