ACETAMINOPHEN; CODEINE PHOSPHATE | A088629 | ANI PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Lachman Consultant Services Inc. FDA-2015-P-1003 · 7 docket documents Lachman Consultant Services, Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that an ANDA may be submitted for Aspirin and Codeine Phosphate Tablets USP in strengths of 300 mg/15 mg, 300 mg/30 mg, 300 mg/45 mg, | Other | 2015-03-31 | Withdrawn | Lachman Consultant Services Inc. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2015-P-1004 · 7 docket documents Lachman Consultant Services, Inc. filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that an ANDA may be submitted for Aspirin and Codeine Phosphate Tablets USP in strengths of 325 mg/15 mg, 325 mg/30 mg, 325 mg/45 mg, and 325 | 505(q) | 2015-03-31 | Withdrawn | Lachman Consultant Services, Inc. |
Citizen Pettion Request from Lachman Consultant Services Inc FDA-2015-P-0516 · 6 docket documents Lachman Consultant Services, Inc. filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the Commissioner determine that an ANDA may be submitted for Aspirin and Codeine Phosphate Tablets USP, in strengths of 300 mg/15 mg, 300 mg/30 mg, and 300 mg/ | 505(q) | 2015-02-18 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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