Acne Vulgaris

• FDA approval · 2018-03-23
  FDA Approved: DIFFERIN — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental application for DIFFERIN (adapalene) from Galderma Laboratories, L.P.

• FDA approval · 2018-01-24
  FDA Approved: ADAPALENE AND BENZOYL PEROXIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's original abbreviated new drug application for Adapalene and Benzoyl Peroxide, a generic topical combinatio…

• FDA approval · 2018-01-23
  FDA Approved: ADAPALENE AND BENZOYL PEROXIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved Padagis Israel Pharmaceuticals Ltd's Adapalene and Benzoyl Peroxide combination as an Original Application (ANDA) product f…

• FDA approval · 2017-12-22
  FDA Approved: TAZAROTENE — Original Application (Mayne Pharma)

  FDA approved Mayne Pharma's original ANDA for tazarotene, enabling the generic topical retinoid product to enter the market.

• FDA approval · 2017-12-15
  FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved an original application for Clindamycin Phosphate and Benzoyl Peroxide, a topical acne treatment manufactured by Sun Pharmaceut…

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• FDA approval · 2017-09-29
  FDA Approved: ISOTRETINOIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC's isotretinoin as a generic version under an Original Application (ANDA 207792) for the treatment…

• 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 · 2017-07-11
  FDA Approved: ADAPALENE — Supplemental Application (CALL INC. (dba Rochester Pharmaceuticals))

  FDA approved a supplemental application for adapalene, signaling changes to the existing approval (e.g., labeling or formulation).

• FDA approval · 2017-06-27
  FDA Approved: CLINDAMYCIN AND BENZOYL PEROXIDE — Original Application (Encube Ethicals, Inc.)

  FDA approved an original generic application for a topical combination of clindamycin and benzoyl peroxide by Encube Ethicals, Inc.

• FDA approval · 2017-06-17
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Claravis (isotretinoin) from Teva Pharmaceuticals USA, Inc., indicating an update related to…

• FDA approval · 2017-06-17
  FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental ANDA for AMNESTEEM (isotretinoin) from Mylan Pharmaceuticals. This approval confirms a generic version of the br…

• FDA approval · 2017-06-17
  FDA Approved: ISOTRETINOIN — Supplemental Application (Mayne Pharma)

  FDA approved a supplemental application for isotretinoin submitted by Mayne Pharma.

• FDA approval · 2017-06-17
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for CLARAVIS (isotretinoin) from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2017-06-17
  FDA Approved: ZENATANE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Zenatane (isotretinoin) with BluePoint Laboratories as the manufacturer.

• FDA approval · 2017-05-19
  FDA Approved: DIFFERIN — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental application for DIFFERIN (adapalene) submitted by Galderma Laboratories, L.P.

• FDA approval · 2017-04-03
  FDA Approved: TAZAROTENE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' generic tazarotene via an original ANDA submission.

• FDA approval · 2016-12-23
  FDA Approved: TRETINOIN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's generic tretinoin under an Original Application, broadening access to tretinoin products.

• 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 · 2016-09-01
  FDA Approved: CLINDAMYCIN PHOSPHATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for clindamycin phosphate by Sun Pharmaceutical Industries, Inc. This is for a generic antibiotic pr…

• FDA approval · 2016-07-08
  FDA Approved: ZENATANE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for ZENATANE (isotretinoin) from BluePoint Laboratories.

• FDA approval · 2016-07-08
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Claravis (isotretinoin) by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2016-07-08
  FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental Abbreviated New Drug Application for AMNESTEEM, a generic isotretinoin product from Mylan Pharmaceuticals.

• FDA approval · 2016-07-08
  FDA Approved: DIFFERIN — Supplemental Application (Galderma Laboratories, L.P.)

  The FDA approved a supplemental application for DIFFERIN (adapalene) submitted by Galderma Laboratories, L.P.

• FDA approval · 2016-07-08
  FDA Approved: ISOTRETINOIN — Supplemental Application (Mayne Pharma)

  FDA approved a supplemental application for isotretinoin from Mayne Pharma.

• FDA approval · 2016-07-08
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for CLARAVIS (isotretinoin) filed by Teva Pharmaceuticals USA, Inc. The action pertains to changes t…