Bacterial Infections

• FDA approval · 2024-11-19
  FDA Approved: ERYTHROMYCIN LACTOBIONATE — Original Application (Gland Pharma Limited)

  FDA approved the original application for erythromycin lactobionate from Gland Pharma Limited (ANDA216761). This marks the approval of a gen…

• EMA approval · 2024-04-03
  EMA Authorised: Ertapenem SUN (ertapenem sodium) — SUN Pharmaceutical Industries (Europe) B.V.

  The EMA authorised Ertapenem SUN (ertapenem sodium) by SUN Pharmaceutical Industries (Europe) B.V. for bacterial infections.

• FDA approval · 2023-01-20
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (HIKMA PHARMACEUTICALS USA INC.)

  FDA approved vancomycin hydrochloride from Hikma Pharmaceuticals USA as an original application, introducing a new antimicrobial product. Th…

• FDA approval · 2021-05-24
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for vancomycin hydrochloride from Hospira, Inc.

• FDA approval · 2020-07-27
  FDA Approved: OXACILLIN — Original Application (Fresenius Kabi USA, LLC)

  FDA approves Fresenius Kabi USA, LLC's Oxacillin sodium as an original-application (ANDA) generic antibiotic. It is indicated for infections…

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• FDA approval · 2020-05-18
  FDA Approved: CLINDAMYCIN IN 5 PERCENT DEXTROSE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for CLINDAMYCIN IN 5 PERCENT DEXTROSE from Sandoz Inc, establishing this generic formulation of …

• FDA approval · 2018-07-10
  FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Mylan Institutional LLC)

  FDA approved an Original Application for vancomycin hydrochloride from Mylan Institutional LLC, confirming its use for treating serious infe…

• FDA approval · 2016-05-12
  FDA Approved: CLINDAMYCIN PHOSPHATE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved the supplemental application for clindamycin phosphate (Padagis Israel Pharmaceuticals Ltd), reflecting approval of the supplem…

• FDA approval · 2016-01-21
  FDA Approved: CLEOCIN HYDROCHLORIDE — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for CLEOCIN HYDROCHLORIDE (clindamycin hydrochloride) filed by Pharmacia & Upjohn Company LLC.

• FDA approval · 2015-08-18
  FDA Approved: DEMECLOCYCLINE HYDROCHLORIDE — Original Application (PuraCap Laboratories LLC)

  FDA approved demeclocycline hydrochloride under an Original Application for PuraCap Laboratories LLC (ANDA065447).

• FDA approval · 2014-12-05
  FDA Approved: METRONIDAZOLE — Supplemental Application (Oceanside Pharmaceuticals)

  The FDA approved a supplemental application for metronidazole submitted by Oceanside Pharmaceuticals.

• FDA approval · 2014-10-15
  FDA Approved: LINCOCIN — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for LINCOCIN (lincomycin hydrochloride) from Pharmacia & Upjohn Company LLC.

• FDA approval · 2012-05-31
  FDA Approved: CLINDAMYCIN IN 5 PERCENT DEXTROSE — Original Application (Sandoz Inc)

  The FDA approved an Original Application for a generic clindamycin in 5% dextrose injection by Sandoz Inc.

• FDA approval · 2011-09-30
  FDA Approved: CLINDAMYCIN — Original Application (Sagent Pharmaceuticals)

  FDA approved Sagent Pharmaceuticals' original application for CLINDAMYCIN PHOSPHATE (clindamycin), a generic antibiotic for treating suscept…

• FDA approval · 2009-08-26
  FDA Approved: CLINDAMYCIN HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for Clindamycin Hydrochloride from Aurobindo Pharma Limited, adding a generic clindamycin HCl product …