ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE | A070116 | MUTUAL PHARMACEUTICAL CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Mikart, Inc. FDA-1999-P-4073 · 7 docket documents Mikart, Incorporated filed a suitability petition requesting that the FDA amend the list of Drug Products Suitable for Abbreviated New Drug Applications to include Propoxyphene Napsylate and Acetaminophen Tablets/Capsules 50 mg/500 mg, a lower-strength variant of the reference listed drug DARVOCET-N | Other | 2017-07-24 | Denied | Mikart, Inc. |
Citizen Petition from Mikart, Inc. FDA-1999-P-0043 · 8 docket documents Mikart, Incorporated filed a suitability petition on July 2, 1999, requesting that the FDA amend the list of Drug Products Suitable for Abbreviated New Drug Applications to include Propoxyphene Napsylate and Acetaminophen 100 mg/325 mg in tablet and capsule forms under 505(j)(2)(A) and (c), based on | Other | 2017-04-26 | Granted | Mikart, Inc. |
Citizens Petition from Frommer Lawrence & Haug LLP FDA-2002-P-0443 · 6 docket documents Frommer Lawrence & Haug LLP filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA authorization to submit an abbreviated new drug application (ANDA) for propoxyphene napsylate and acetaminophen oral tablets in strengths of 100 mg/325 | Other | 2009-11-24 | Withdrawn | Frommer Lawrence & Haug LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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