CLINDAMYCIN PHOSPHATE | A064050 | PADAGIS US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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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