Acne Vulgaris
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-11-08FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for CLARAVIS (isotretinoin) from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2021-11-08FDA Approved: ISOTRETINOIN — Supplemental Application (Mayne Pharma)
FDA approved a supplemental application for isotretinoin from Mayne Pharma, indicating an additional regulatory approval for this product un…
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FDA approval · 2021-11-08FDA Approved: ISOTRETINOIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
The FDA approved a supplemental application for isotretinoin from Amneal Pharmaceuticals NY LLC.
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FDA approval · 2021-10-08FDA Approved: ISOTRETINOIN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for isotretinoin from Actavis Pharma, Inc., resulting in changes to the product labeling under the A…
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FDA approval · 2021-10-08FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for CLARAVIS (isotretinoin) by Teva Pharmaceuticals USA, Inc.
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FDA approval · 2021-10-08FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Amnesteem (isotretinoin) submitted by Mylan Pharmaceuticals Inc., representing an approval of a …
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FDA approval · 2021-10-08FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for CLARAVIS (isotretinoin) submitted by Teva Pharmaceuticals USA, Inc.
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FDA approval · 2021-10-08FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for ABSORICA (isotretinoin) filed by Sun Pharmaceutical Industries, Inc. The approval may involv…
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FDA approval · 2021-10-08FDA Approved: ABSORICA LD — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for ABSORICA LD (isotretinoin) submitted by Sun Pharmaceutical Industries, Inc.
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FDA approval · 2021-10-08FDA Approved: ISOTRETINOIN — Supplemental Application (Upsher-Smith Laboratories, LLC)
The FDA approved a supplemental application for isotretinoin submitted by Upsher-Smith Laboratories, LLC.
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FDA approval · 2021-10-08FDA Approved: ISOTRETINOIN — Supplemental Application (Upsher-Smith Laboratories, LLC)
FDA approved a supplemental application for isotretinoin by Upsher-Smith Laboratories, updating the product labeling.
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FDA approval · 2021-10-08FDA Approved: ISOTRETINOIN — Supplemental Application (Mayne Pharma)
The FDA has approved a supplemental application for isotretinoin submitted by Mayne Pharma.
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FDA approval · 2021-10-08FDA Approved: ISOTRETINOIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for isotretinoin by Amneal Pharmaceuticals NY LLC under an ANDA.
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FDA approval · 2021-09-21FDA Approved: ISOTRETINOIN — Original Application (Upsher-Smith Laboratories, LLC)
FDA approves the original application for isotretinoin from Upsher-Smith Laboratories, LLC, for the treatment of acne vulgaris.
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FDA approval · 2021-08-19FDA Approved: WINLEVI — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for WINLEVI (clascoterone) by Sun Pharmaceutical Industries, expanding its labeling for acne vul…
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FDA approval · 2021-07-26FDA Approved: TWYNEO — Original Application (Galderma Laboratories, L.P.)
FDA approved TWYNEO, a fixed-dose combination of tretinoin and benzoyl peroxide, for acne vulgaris under Galderma Laboratories, L.P.'s origi…
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FDA approval · 2021-04-28FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Original Application (Northstar Rx LLC)
The FDA approved a generic clindamycin phosphate and benzoyl peroxide topical combination for the treatment of acne vulgaris (ANDA 212433; O…
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FDA approval · 2021-04-12FDA Approved: ISOTRETINOIN — Original Application (Upsher-Smith Laboratories, LLC)
FDA approved Upsher-Smith Laboratories, LLC's isotretinoin under an Original Application (ANDA) for the treatment of severe acne.
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FDA approval · 2021-03-31FDA Approved: ISOTRETINOIN — Original Application (Actavis Pharma, Inc.)
FDA approves Actavis's original ANDA for isotretinoin (generic) for the treatment of severe acne. This confirms a generic version of isotret…
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FDA approval · 2021-03-18FDA Approved: CLINDAMYCIN PHOAPHATE TOPICAL SOLUTION USP, 1% — Supplemental Application (Encube Ethicals, Inc.)
FDA approves a supplemental application for CLINDAMYCIN PHOAPHATE TOPICAL SOLUTION USP, 1% (ANDA 209914) by Encube Ethicals, Inc.
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FDA approval · 2021-03-11FDA Approved: CLINDAMYCIN PHOSPHATE — Original Application (Encube Ethicals, Inc.)
FDA approved Clindamycin Phosphate Gel USP, 1% (Original Application) from Encube Ethicals, Inc.
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FDA approval · 2020-12-31FDA Approved: CLINDAMYCIN PHOSPHATE — Original Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved a new original application for clindamycin phosphate, a generic formulation manufactured by Padagis Israel Pharmaceuticals Ltd.
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FDA approval · 2020-12-09FDA Approved: ZENATANE — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for Zenatane (isotretinoin) submitted by BluePoint Laboratories.
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FDA approval · 2020-12-09FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves a supplemental application for CLARAVIS (isotretinoin) from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2020-12-09FDA Approved: ISOTRETINOIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
The FDA approved a supplemental application for isotretinoin by Amneal Pharmaceuticals NY LLC. This action approves a change to the approved…