KETOCONAZOLE | A075273 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from B&H Consulting Services, Inc. FDA-2017-P-5845 · 4 docket documents B&H Consulting Services, Inc. filed this petition requesting that the FDA designate the drug product listed in ANDA 075597 (Mylan Pharmaceuticals Inc.) as a new Reference Standard for Ketoconazole Tablets USP, 200 mg, because the current Reference Standard product from Teva Pharmaceuticals Inc. (AND | 505(q) | 2017-09-21 | Open | B&H Consulting Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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