ASPIRIN; HYDROCODONE BITARTRATE | A205479 | LGM PHARMA SOLUTIONS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lachman Consultant Services, Inc. - Citizen Petition FDA-2010-P-0338 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether Azdone (hydrocodone bitartrate and aspirin) Tablets, 5 mg/500 mg, held by Schwarz Pharma under ANDA 89-420, was voluntarily withdrawn or withheld from sale for reasons of safety or e | 505(q) | 2010-06-28 | Granted | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2008-P-0438 · 3 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of an unnamed client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA declare Hydrocodone Bitartrate and Aspirin Tablets in four strengths (2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, | Other | 2008-08-01 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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