LINDANE | N010718 | REED AND CARNRICK PHARMACEUTICALS DIV BLOCK DRUG CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Husch Blackwell LLP FDA-2024-P-4291 Husch Blackwell LLP, on behalf of a client, filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Clonidine Hydrochloride Tablet USP, 0.05 mg suitable for submission in an ANDA based on the reference-listed drug Catapres (NDA 1 | Suitability | 2024-09-10 | Open | Husch Blackwell LLP |
Citizen Petition from Husch Blackwell LLP on behalf of Brenntag Great Lakes LLC FDA-2021-P-0576 Brenntag Great Lakes LLC, filed through counsel at Husch Blackwell LLP, petitioned the FDA on June 24, 2021, requesting that the agency expand its exemption from the Over-the-Counter Monograph Drug Facility Fee under Section 774M of the Federal Food Drug and Cosmetic Act to include active pharmaceut | Other | 2021-06-25 | Open | Husch Blackwell LLP on behalf of Brenntag Great Lakes LLC |
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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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