ACETAMINOPHEN; HYDROCODONE BITARTRATE | A040122 | WATSON LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from PAI, Pharmaceutical Associates, Inc. FDA-2001-P-0298 · 4 docket documents Pharmaceutical Associates, Inc. filed this citizen petition under section 505(j)(2)(c) requesting that the FDA declare an abbreviated new drug application (ANDA) suitable for a hydrocodone bitartrate and acetaminophen elixir containing 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen per 15 mL | Other | 2025-06-27 | Granted | PAI, Pharmaceutical Associates, Inc. |
Citizen Petition from Mikart, Inc. FDA-1995-P-0100 · 4 docket documents Mikart, Incorporated filed an ANDA Suitability Petition under 21 U.S.C. 505(j)(2)(A) and (C) requesting that the FDA amend Docket No. 82N 0032 to include Hydrocodone Bitartrate and Acetaminophen Capsules in 5 mg/325 mg strength as suitable for an abbreviated new drug application, citing the prior ap | Other | 2017-04-10 | Granted | Mikart, Inc. |
Citizen Petition from Pharmaceutical Associates, Inc. FDA-2000-P-0565 · 3 docket documents Pharmaceutical Associates, Inc. filed this citizen petition on November 28, 2000, requesting that the FDA declare that abbreviated new drug applications may be submitted for a higher-strength hydrocodone bitartrate and acetaminophen elixir containing 10 mg of hydrocodone bitartrate and 325 mg of ace | Other | 2014-03-16 | Granted | Pharmaceutical Associates, Inc. |
Lannett Company, Inc. - Citizen Petition FDA-2012-P-0964 · 3 docket documents Lannett Company, Inc. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine that Abbreviated New Drug Applications may be submitted for hydrocodone bitartrate and acetaminophen tablets in strengths of 2.5 mg | 505(q) | 2012-09-20 | Withdrawn | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2011-P-0302 · 4 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 declare Hydrocodone Bitartrate and Acetaminophen Effervescent Tablets in strengths of 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 | Other | 2011-05-25 | Denied | — |
Citizen Petition from Arnall Golden Gregory LLP FDA-2006-P-0278 · 19 docket documents The law firm Kleinfeld, Kaplan and Becker submitted this citizen petition under Section 505(j)(2)(C) on behalf of a client requesting that FDA declare Hydrocodone Bitartrate and Acetaminophen Orally Disintegrating Tablets at 5 mg/500 mg suitable for submission as an ANDA, with the only change from t | Other | 2009-04-23 | Withdrawn | Arnall Golden Gregory LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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