ASPIRIN; BUTALBITAL; CAFFEINE | N017534 | ALLERGAN SALES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services Inc FDA-2014-P-2168 · 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 FDA declare Aspirin 300 mg, Butalbital 50 mg, Caffeine 40 mg, and Codeine Phosphate 30 mg Capsules suitable for submission as an ANDA, with Fiorinal with Co | Other | 2014-12-11 | Withdrawn | Lachman Consultant Services Inc |
Citizen Petition Request from Lachman Consultant Services Inc FDA-2014-P-2169 · 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 FDA declare Aspirin 300 mg, Butalbital 50 mg and Caffeine 40 mg Capsules suitable for submission as an ANDA, with the reference listed drug being Fiorinal Cap | Other | 2014-12-11 | Withdrawn | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2008-P-0156 · 3 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 declare Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules USP (50 mg/500 mg/40 mg/30 mg) suitable for submission as an ANDA, with Fiorinal | Other | 2008-09-05 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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