HYDROCODONE BITARTRATE AND IBUPROFEN

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

FDA-1985-P-0501 · 15 docket documents

Russ Pharmaceuticals, Inc. submitted a Section 505 citizen petition requesting that the FDA declare a drug product suitable for an abbreviated new drug application (ANDA). The product is a tablet containing 2.5 milligrams of hydrocodone bitartrate and 500 milligrams of acetaminophen indicated for re

FDA-2017-P-5370 · 13 docket documents

Dennis Ryll filed this citizen petition requesting that the FDA amend black box warnings on all Schedule II opioid analgesics (such as morphine, hydrocodone, and oxycodone) to warn prescribers and patients that Schedule III opioids like buprenorphine carry significantly lower risks of addiction and

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

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

FDA-2013-P-1711 · 3 docket documents

Morgan, Lewis & Bockius LLP, representing an unnamed client, filed this citizen petition on December 26, 2013, opposing the FDA's recommendation to reclassify hydrocodone combination products from Schedule III to Schedule II under the Controlled Substances Act. The petitioner requests that if resche

FDA-2012-P-1267 · 3 docket documents

Xspire Pharma, LLC filed an ANDA Suitability Petition under 21 CFR 314.93 requesting permission to submit an abbreviated new drug application for Aspradone (Aspirin, Hydrocodone Bitartrate Tablets, 325 mg/5 mg) with a different strength than the reference listed drug ANDA A089-420 for Azdone (Aspiri

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

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

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

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

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,

FDA-2007-P-0004 · 8 docket documents

Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Hydrocodone Bitartrate and Homatropine Methylbromide Syrup at a lower strength of 2.5 mg/0.75 mg per 5 mL suitable for submission as an abbreviated new drug application, with the reference lis

FDA-2007-P-0176 · 7 docket documents

Lachman Consultant Services, Inc. filed this citizen petition on August 2, 2007, pursuant to Section 505(j)(2)(C) requesting that the FDA declare Hydrocodone Bitartrate and Homatropine Methylbromide Capsules, 5 mg/1.5 mg, suitable for submission as an abbreviated new drug application based on the re

FDA-2007-P-0124 · 7 docket documents

Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA declare Hydrocodone Bitartrate and Homatropine Methylbromide Tablets at 2.5 mg/0.75 mg suitable for submission as an ANDA, with the reference listed drug being Hycodan at 5 mg/1.5 mg (NDA 05-2