ESTRADIOL | N020472 | PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pfizer, Inc. FDA-2017-P-5081 Pfizer Inc. filed this citizen petition on August 17, 2017, requesting that the FDA issue a product-specific bioequivalence guidance document for generic versions of Estring (estradiol vaginal ring) under the ANDA pathway. Pfizer requests the guidance establish requirements for demonstration of comp | 505(q) | 2017-08-21 | Denied | Pfizer |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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