Juvenile Idiopathic Arthritis

• FDA approval · 2021-04-28
  FDA Approved: NAPROXEN — Supplemental Application (Acella Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Naproxen filed by Acella Pharmaceuticals, LLC, updating the product's approval status.

• FDA approval · 2021-04-28
  FDA Approved: IBUPROFEN — Supplemental Application (Major Pharmaceuticals)

  The FDA approved Major Pharmaceuticals' ibuprofen supplemental application, finalizing regulatory changes for this product under an ANDA pro…

• FDA approval · 2021-03-29
  FDA Approved: LEFLUNOMIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved an original-application generic for Leflunomide from Aurobindo Pharma Limited.

• FDA approval · 2021-02-24
  FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)

  FDA approval of a supplemental application for the adalimumab biosimilar ADALIMUMAB-ADAZ from Sandoz Inc.

• FDA approval · 2021-01-15
  FDA Approved: AZULFIDINE EN-TABS — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for AZULFIDINE EN-TABS (sulfasalazine) from Pfizer, resulting in updated labeling and/or approved in…

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• FDA approval · 2020-12-03
  FDA Approved: CELECOXIB — Original Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved the original ANDA for Celecoxib from ScieGen Pharmaceuticals, a generic version of the COX-2 inhibitor used for pain relief. It…

• FDA approval · 2020-07-28
  FDA Approved: NAPROXEN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Naproxen from Glenmark Pharmaceuticals to update the labeling for the generic product under the …

• FDA approval · 2020-07-06
  FDA Approved: HULIO — Original Application (Biocon Biologics Inc)

  FDA approved HULIO (adalimumab-fkjp) from Biocon Biologics Inc via an original Biologics License Application, a biosimilar to adalimumab. Th…

• FDA approval · 2020-06-01
  FDA Approved: MELOXICAM — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' MELOXICAM as an original-application generic meloxicam; the drug is indicated for relief of pain and inf…

• FDA approval · 2020-03-19
  FDA Approved: NAPROXEN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's supplemental application for naproxen (generic) under ANDA075390. This action constitutes a suppleme…

• FDA approval · 2020-03-06
  FDA Approved: CELECOXIB — Original Application (Chartwell RX, LLC)

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

• FDA approval · 2020-02-25
  FDA Approved: CELECOXIB — Original Application (EPIC PHARMA, LLC)

  FDA approved the Original Application (ANDA) for a generic Celecoxib product from Epic Pharma, LLC, enabling its marketing as a COX-2 inhibi…

• FDA approval · 2019-12-02
  FDA Approved: MELOXICAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for meloxicam by Aurobindo Pharma Limited. The approval covers changes approved under this supplemen…

• FDA approval · 2019-11-27
  FDA Approved: CELECOXIB — Original Application (NIVAGEN PHARMACEUTICALS, INC.)

  The FDA approved NIVAGEN Pharmaceuticals, Inc.'s original application for a generic celecoxib product.

• FDA approval · 2019-11-15
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for a generic Naproxen product from Hikma Pharmaceuticals USA Inc. This action expands access to…

• FDA approval · 2019-11-14
  FDA Approved: CELECOXIB — Original Application (Modavar Pharmaceuticals LLC)

  The FDA approved Modavar Pharmaceuticals LLC's original application for a generic version of celecoxib (Celecoxib).

• FDA approval · 2019-10-26
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., resulting in an approved modification to the product’s lab…

• FDA approval · 2019-10-22
  FDA Approved: MELOXICAM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for Meloxicam from Unichem Pharmaceuticals (USA), Inc. under ANDA 077927.

• FDA approval · 2019-10-09
  FDA Approved: CELECOXIB — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Celecoxib submitted by Actavis Pharma, Inc.

• FDA approval · 2019-08-30
  FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ (tofacitinib) submitted by Pfizer Laboratories Div Pfizer Inc, marking an approved modif…

• FDA approval · 2019-08-07
  FDA Approved: CELECOXIB — Original Application (AiPing Pharmaceutical, Inc.)

  The FDA approved AiPing Pharmaceutical, Inc.'s original ANDA for celecoxib, establishing a generic version of the COX-2 inhibitor. The appro…

• FDA approval · 2019-07-25
  FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA entry describing a supplemental application for XELJANZ (tofacitinib) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2019-07-25
  FDA Approved: CELECOXIB — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for celecoxib from Apotex Corp., granting approval for a generic version of the product.

• FDA approval · 2019-07-25
  FDA Approved: CELECOXIB — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's supplemental application for Celecoxib (generic Celecoxib), confirming the generic's approval. Celec…

• FDA approval · 2019-07-25
  FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ XR (tofacitinib extended-release), expanding its formulation under Pfizer's submission.