CLINDAMYCIN PHOSPHATE | N050537 | PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Husch Blackwell, LLP FDA-2019-P-5403 Husch Blackwell LLP, on behalf of an unnamed client, filed a citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate ANDA No. 065049 (Clindamycin Phosphate Topical Solution USP, 1% (Pledgets)) by Perrigo New York, Inc. as a Reference Standa | 505(q) | 2019-11-15 | Open | Husch Blackwell |
Citizen Petition from Macleods Pharmaceuticals Limited FDA-2019-P-4481 Macleods Pharmaceuticals Limited submitted this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate the approved generic product ANDA #064050, Clindamycin phosphate topical solution 1% manufactured by Perrigo New York Inc., as a referen | Other | 2019-09-26 | Denied | Macleods Pharmaceuticals Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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