Cough

• FDA approval · 2017-02-21
  FDA Approved: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — Original Application (KVK-Tech, Inc.)

  FDA approved a generic hydrocodone bitartrate and homatropine methylbromide oral solution from KVK-Tech, Inc. for the relief of cough.

• FDA approval · 2017-02-13
  FDA Approved: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — Original Application (Novel Laboratories, Inc.)

  FDA approved Novel Laboratories, Inc.'s generic hydrocodone bitartrate and homatropine methylbromide tablets (Original Application) for coug…

• FDA approval · 2017-01-13
  FDA Approved: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approves Cosette Pharmaceuticals' supplemental application for promethazine hydrochloride and codeine phosphate, a generic combination p…

• FDA approval · 2016-12-15
  FDA Approved: HYDROMET — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for HYDROMET (hydrocodone bitartrate and homatropine methylbromide) from Actavis Pharma.

• FDA approval · 2016-09-20
  FDA Approved: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE — Original Application (Acella Pharmaceuticals, LLC)

  FDA approved an original application for a generic combination product containing brompheniramine maleate, pseudoephedrine hydrochloride, an…

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• FDA approval · 2016-08-25
  FDA Approved: TUXARIN — Supplemental Application (Mainpointe Pharmaceuticals)

  FDA approved a supplemental application for TUXARIN (codeine phosphate and chlorpheniramine maleate) from Mainpointe Pharmaceuticals. The ap…

• FDA approval · 2015-07-31
  FDA Approved: BENZONATATE — Original Application (TAGI Pharma, Inc.)

  The FDA approved TAGI Pharma, Inc.'s original application for benzonatate, establishing the availability of this generic cough suppressant.

• FDA approval · 2015-07-30
  FDA Approved: BENZONATATE — Original Application (Strides Pharma Science Limited)

  FDA approves Strides Pharma Science Limited's generic Benzonatate through an Original Application (ANDA) for relief of cough.

• FDA approval · 2012-09-28
  FDA Approved: TOPCARE COUGH DM — Supplemental Application (Topco Associates LLC)

  FDA approved a supplemental application for TOPCARE COUGH DM (dextromethorphan polistirex) from Topco Associates LLC. It is an extended-rele…

• FDA approval · 2012-06-29
  FDA Approved: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE — Original Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved Cosette Pharmaceuticals' generic promethazine hydrochloride and codeine phosphate (ANDA 200386). This marks the original ap…

• FDA approval · 2012-06-28
  FDA Approved: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE — Original Application (Cranbury Pharmaceuticals, LLC)

  FDA approved Cranbury Pharmaceuticals' generic Promethazine hydrochloride and dextromethorphan hydrobromide product under an Original Applic…

• FDA approval · 2012-05-25
  FDA Approved: TOPCARE COUGH DM — Original Application (Topco Associates LLC)

  FDA approved the generic TOPCARE COUGH DM containing dextromethorphan polistirex under an Original Application (ANDA 091135) for cough relie…

• FDA approval · 2011-06-22
  FDA Approved: ACETAMINOPHEN AND CODEINE PHOSPHATE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for Acetaminophen and Codeine Phosphate from SpecGx LLC.

• FDA approval · 2011-05-16
  FDA Approved: DELSYM — Supplemental Application (RB Health (US) LLC)

  The FDA approved a supplemental application for DELSYM (dextromethorphan) submitted by RB Health (US) LLC.

• FDA approval · 2011-04-20
  FDA Approved: BENZONATATE — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for BENZONATATE from Bionpharma Inc., confirming an additional approval for this generic cough suppr…

• FDA approval · 2011-04-20
  FDA Approved: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approved Lupin Pharmaceuticals' generic hydrocodone bitartrate and homatropine methylbromide tablet, an opioid antitussive indicated for…

• FDA approval · 2011-03-03
  FDA Approved: BENZONATATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Benzonatate by Zydus Pharmaceuticals USA Inc., authorizing changes under the ANDA.

• FDA approval · 2011-03-01
  FDA Approved: BENZONATATE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for BENZONATATE submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2010-10-01
  FDA Approved: HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE — Original Application (Cranbury Pharmaceuticals, LLC)

  FDA approved the original application for Hydrocodone polistirex and chlorpheniramine polistirex extended-release, a fixed-dose combination …

• FDA approval · 2010-04-06
  FDA Approved: BENZONATATE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for BENZONATATE from Amneal Pharmaceuticals LLC under an ANDA. The action approves changes submi…

• FDA approval · 2009-10-08
  FDA Approved: DELSYM — Supplemental Application (RB Health (US) LLC)

  FDA approved a supplemental application for Delsym (dextromethorphan) submitted by RB Health (US) LLC.

• FDA approval · 2008-12-05
  FDA Approved: DELSYM — Supplemental Application (RB Health (US) LLC)

  FDA approves a supplemental application for Delsym (dextromethorphan) filed by RB Health (US) LLC.

• FDA approval · 2008-04-02
  FDA Approved: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Promethazine hydrochloride and dextromethorphan hydrobromide by ANI Pharmaceuticals Inc.

• FDA approval · 2007-10-30
  FDA Approved: BENZONATATE — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Benzonatate by Bionpharma Inc. (ANDA 081297), resulting in supplemental approval for the generic…

• FDA approval · 2007-06-08
  FDA Approved: BENZONATATE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves the original application for benzonatate from Zydus Pharmaceuticals USA Inc.