CLINDAMYCIN PHOSPHATE; TRETINOIN | N050802 | BAUSCH HEALTH US LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Medicis Pharmaceutical Corporation et al v. Actavis Mid Atlantic LLC 2 patentsANDA 202564Clindamycin phosphate and tretinoin | D. Del. | 2011-05-11 | Terminated 2013-04-12 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from REGCON Solutions LLC (Akorn Inc) FDA-2015-P-1449 · 4 docket documents REGCON Solutions LLC filed this citizen petition on behalf of Akorn Inc. requesting that the FDA amend the Orange Book to designate Akorn's Phenylephrine hydrochloride ophthalmic solution/drops 2.5% and 10% (NDA 207926) as a second reference-listed drug under Section 505(j), arguing that without thi | 505(q) | 2015-05-08 | Granted | REGCON Solutions LLC (Akorn Inc) |
Actavis, Inc. - Citizen Petition FDA-2011-P-0606 · 4 docket documents Actavis, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Veltin (clindamycin phosphate and tretinoin) Topical Gel, 1.2%/0.025%, NDA 50803, as a second reference-listed drug to enable the submission of an ANDA for a g | 505(q) | 2011-09-01 | Granted | — |
Citizen Petition from E. Tanghetti, MD FDA-2006-P-0267 · 5 docket documents E. Tanghetti, MD, filed this petition on December 15, 2006, requesting that the FDA withdraw approval of and recall Ziana, a topical combination product containing clindamycin phosphate 1.2% and tretinoin 0.025%, or alternatively require long-term safety studies to evaluate antibiotic resistance ass | Other | 2008-11-15 | Denied | E. Tanghetti, MD |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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