Nocturnal Enuresis

• FDA approval · 2026-02-27
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Caplin Steriles Limited)

  FDA approved Desmopressin Acetate from Caplin Steriles Limited under an Original Application (ANDA). This marks the approval of a generic De…

• FDA approval · 2026-02-25
  FDA Approved: DESMODA — Original Application (Eton Pharmaceuticals, Inc.)

  FDA approves DESMODA (desmopressin acetate oral solution) under an original NDA from Eton Pharmaceuticals; the product provides a new oral f…

• FDA approval · 2025-08-27
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Avenacy, Inc.)

  FDA approved a supplemental application for Desmopressin Acetate by Avenacy, Inc.

• FDA approval · 2025-06-24
  FDA Approved: IMIPRAMINE PAMOATE — Supplemental Application (Hikma Pharmaceuticals USA Inc)

  FDA approved a supplemental application for Imipramine Pamoate by Hikma Pharmaceuticals USA Inc, enabling a generic imipramine pamoate produ…

• FDA approval · 2024-03-21
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Aurobindo Pharma Limited)

  FDA approved desmopressin acetate from Aurobindo Pharma Limited under an original abbreviated new drug application (ANDA213095).

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• FDA approval · 2023-05-01
  FDA Approved: IMIPRAMINE HYDROCHLORIDE — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application for imipramine hydrochloride from Strides Pharma Science Limited, enabling continued marketing o…

• FDA approval · 2023-05-01
  FDA Approved: IMIPRAMINE HYDROCHLORIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for imipramine hydrochloride by Strides Pharma Science Limited, a generic antidepressant.

• FDA approval · 2023-03-20
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Sun Pharmaceutical Industries Limited)

  FDA approved a generic version of Desmopressin Acetate from Sun Pharmaceutical Industries Limited under an original ANDA.

• FDA approval · 2022-11-16
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the Original Application for Desmopressin Acetate from Fresenius Kabi USA, LLC (ANDA216922). This marks the approval of a gener…

• FDA approval · 2022-08-19
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved Desmopressin Acetate from Dr. Reddy's Laboratories Inc. via an Original Application for a generic product.

• FDA approval · 2020-02-14
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Dr.Reddys' Laboratories Inc)

  FDA approved an original application for Desmopressin Acetate from Dr. Reddy's Laboratories Ltd., a generic version of desmopressin acetate.

• FDA approval · 2019-10-24
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Apotex Corp.)

  FDA approves Apotex Corp.'s supplemental application for Desmopressin Acetate, enabling the generic version to be marketed.

• FDA approval · 2019-01-28
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (KVK-TECH, INC.)

  The FDA approved Desmopressin Acetate from KVK-Tech under an Original Application, providing a new generic option for this drug product.

• FDA approval · 2017-08-22
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Sagent Pharmaceuticals)

  FDA approved the Original Application for Desmopressin Acetate (DESMOPRESSIN ACETATE) by Sagent Pharmaceuticals, providing a generic version…

• FDA approval · 2017-08-22
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Sagent Pharmaceuticals)

  FDA approved an original application for Desmopressin Acetate from Sagent Pharmaceuticals, establishing a generic version of the product.

• FDA approval · 2017-05-26
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an Original Application for Desmopressin Acetate as a generic product manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet …

• FDA approval · 2016-02-02
  FDA Approved: IMIPRAMINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for imipramine hydrochloride (ANDA 090441), a generic antidepressant.

• FDA approval · 2015-05-28
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Glenmark Pharmaceuticals Inc.,USA)

  The FDA approved Glenmark's Desmopressin Acetate as an Original Application (ANDA201831), authorizing the generic product to be marketed for…

• FDA approval · 2015-01-23
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Desmopressin Acetate from Apotex Corp. under an ANDA.

• FDA approval · 2015-01-14
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Bauch & Lomb Incorporated)

  FDA approved a supplemental application for desmopressin acetate from Bauch & Lomb Incorporated under an ANDA.

• FDA approval · 2014-11-17
  FDA Approved: IMIPRAMINE HYDROCHLORIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  The FDA approved a supplemental application for imipramine hydrochloride (Oxford Pharmaceuticals, LLC).

• FDA approval · 2014-07-17
  FDA Approved: IMIPRAMINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for imipramine hydrochloride by Lupin Pharmaceuticals, confirming continued approval for the generic…

• FDA approval · 2014-02-28
  FDA Approved: DDAVP — Supplemental Application (Ferring Pharmaceuticals Inc.)

  The FDA approved a supplemental application for DDAVP (desmopressin acetate) filed by Ferring Pharmaceuticals Inc. The action updates the pr…

• FDA approval · 2013-01-25
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved an Abbreviated New Drug Application for Desmopressin Acetate from Sun Pharmaceutical Industries, marking a generic product appr…

• FDA approval · 2012-10-24
  FDA Approved: IMIPRAMINE HYDROCHLORIDE — Original Application (Leading Pharma, LLC)

  The FDA approved the original ANDA for a generic imipramine hydrochloride product from Leading Pharma, LLC, enabling marketing of a generic …