Gonorrhea

• FDA approval · 2025-12-12
  FDA Approved: NUZOLVENCE — Original Application (La Jolla Pharmaceutical Company)

  FDA approved NUZOLVENCE (zoliflodacin) under the original application by La Jolla Pharmaceutical Company for the treatment of gonorrhea. Thi…

• FDA approval · 2025-03-31
  FDA Approved: DOXYCYCLINE — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for doxycycline from Par Health USA, LLC under an ANDA, authorizing changes to the generic produ…

• FDA approval · 2024-12-04
  FDA Approved: DOXYCYCLINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's generic doxycycline as an original ANDA product.

• FDA approval · 2024-10-28
  FDA Approved: DOXYCYCLINE — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' generic doxycycline as an Original Application (ANDA 218053), enabling market entry of a doxycycl…

• FDA approval · 2022-01-12
  FDA Approved: AZITHROMYCIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for AZITHROMYCIN submitted by Aurobindo Pharma Limited under an ANDA.

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• FDA approval · 2020-09-09
  FDA Approved: CEFTRIAXONE AND DEXTROSE — Supplemental Application (B. Braun Medical Inc.)

  FDA approved a supplemental application for Ceftriaxone and Dextrose from B. Braun Medical, resulting in an updated/expanded approval for th…

• FDA approval · 2020-05-01
  FDA Approved: AZITHROMYCIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for AZITHROMYCIN from Lupin Pharmaceuticals, Inc., signaling an update to the product's regulatory a…

• FDA approval · 2018-12-07
  FDA Approved: AZITHROMYCIN — Original Application (Lannett Company, Inc.)

  FDA approves Lannett Company, Inc.'s original application for azithromycin (AZITHROMYCIN), a generic antibiotic.

• FDA approval · 2017-09-27
  FDA Approved: DOXYCYCLINE HYCLATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' doxycycline hyclate generic under an Original Application (ANDA).

• FDA approval · 2016-10-18
  FDA Approved: DOXYCYCLINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves a supplemental application for doxycycline from Lupin Pharmaceuticals, Inc. to modify/expand an existing generic product approv…

• FDA approval · 2016-06-29
  FDA Approved: CEFTRIAXONE SODIUM — Original Application (Qilu Pharmaceutical Co., Ltd.)

  FDA approved the Original Application for ceftriaxone sodium from Qilu Pharmaceutical Co., Ltd., a broad-spectrum cephalosporin used to trea…

• FDA approval · 2014-03-05
  FDA Approved: DOXYCYCLINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' generic doxycycline (DOXYCYCLINE) under an original application.

• FDA approval · 2014-03-05
  FDA Approved: CIPROFLOXACIN — Original Application (Chartwell RX, LLC)

  FDA approved the original application for ciprofloxacin (generic) by Chartwell RX, LLC.

• FDA approval · 2013-11-22
  FDA Approved: CEFIXIME — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for cefixime. This action updates the cefixime NDA, potentially expanding i…

• FDA approval · 2013-03-29
  FDA Approved: CEFIXIME — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for cefixime from Lupin Pharmaceuticals, Inc. to modify/extend its labeling and/or approval.

• FDA approval · 2012-06-01
  FDA Approved: CEFIXIME — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' cefixime product under NDA203195 as a generic oral cephalosporin antibiotic.

• FDA approval · 2009-06-18
  FDA Approved: CEFTRIAXONE — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for ceftriaxone sodium (ceftriaxone) from Baxter Healthcare Company, authorizing changes to the appr…