PENICILLIN G POTASSIUM | A060073 | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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 | — |
Citizen Petition from Clinical and Laboratory Standards Institute FDA-2007-P-0299 · 4 docket documents The Clinical and Laboratory Standards Institute filed this citizen petition requesting that the FDA Center for Drug Evaluation and Research update the official drug labels for penicillin G potassium and penicillin G sodium for injection to include newly established nonmeningitis susceptibility break | Other | 2008-05-22 | Withdrawn | Clinical and Laboratory Standards Institute |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.