Cosette
FDA Approves CLOMID — Cosette Pharmaceuticals, Inc.
# FDA Approves Clomiphene Citrate Generic for Cosette Pharmaceuticals Cosette Pharmaceuticals, Inc. received FDA approval for its generic version of ...
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Par
FDA Approves ENDOCET — Par Health USA, LLC
Par Health USA, LLC received FDA approval for the ANDA 040330 to market ENDOCET (oxycodone hydrochloride and acetaminophen), a generic option for the ...
EPIC
FDA Approves MEPERIDINE HYDROCHLORIDE — EPIC PHARMA, LLC
Epic Pharma, LLC obtained FDA approval on May 28, 1999, for oral meperidine hydrochloride, likely securing a supply foothold in a niche segment of the...
ASPEN
FDA Approves Unknown Drug — ASPEN
# FDA Approves ASPEN's New Drug Application The FDA approved ASPEN's new drug application (NDA020992) on March 24, 1999, expanding the pharmaceutical...
ANI
FDA Approves Unknown Drug — ANI PHARMS
FDA approval of ANI PHARMS' ANDA075327 authorizes the commercial launch of the generic version of the prescription substance, positioning the company ...
Haleon
FDA Approves JUNIOR STRENGTH ADVIL — Haleon US Holdings LLC
Haleon US Holdings LLC has received FDA approval for the expanded pediatric indication of Junior Strength Advil (ibuprofen), a reformulation of the ge...
STRIDES
FDA Approves Unknown Drug — STRIDES PHARMA INTL
# FDA Approves Generic Drug Application for Strides Pharma International Strides Pharma International received FDA approval for ANDA 040191 on Decemb...
STRIDES
FDA Approves Unknown Drug — STRIDES PHARMA INTL
STRIDES PHARMA INTL secured FDA approval for its generic product via ANDA075295, a regulatory milestone expected to bolster its portfolio and generate...
Janssen
FDA Approves TOPAMAX — Janssen Pharmaceuticals, Inc.
# FDA Approves Janssen Pharmaceuticals' TOPAMAX (Topiramate) for Oral Use Janssen Pharmaceuticals, Inc. received FDA approval for TOPAMAX (topiramate...
Genentech,
FDA Approves CELLCEPT — Genentech, Inc.
Genentech, Inc. announced the approval of CELLCEPT (mycophenolate mofetil) oral suspension, providing clinicians with a critical liquid formulation to...
Fresenius
FDA Approves FLUOROURACIL — Fresenius Kabi USA, LLC
# FDA Approves Fresenius Kabi's Intravenous Fluorouracil Formulation Fresenius Kabi USA, LLC received FDA approval for its intravenous fluorouracil f...
Genentech,
FDA Approves HERCEPTIN — Genentech, Inc.
# FDA Approves Genentech's Herceptin for HER2-Positive Breast Cancer Genentech's HERCEPTIN (trastuzumab), the first monoclonal antibody approved for ...
Amneal
FDA Approves BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE — Amneal Pharmaceuticals of New York, LLC
Amneal Pharmaceuticals’ recent FDA approval for the generic version of butalbital/aspirin/caffeine/codeine phosphate positions the company to capture ...
NorthStar
FDA Approves LABETALOL HYDROCHLORIDE — NorthStar Rx LLC
# FDA Approves NorthStar Rx LLC's Labetalol Hydrochloride for Oral Administration NorthStar Rx LLC has received FDA approval for its generic labetalo...
SUN
FDA Approves Unknown Drug — SUN PHARM INDUSTRIES
SUN PHARM INDUSTRIES announced FDA approval for ANDA040260, securing a regulatory milestone that adds a new generic option to its portfolio and positi...
Celgene
FDA Approves THALOMID — Celgene Corporation
Celgene Corporation rallied on July 16, 1998, following the FDA's approval of its oral Thalomid (thalidomide) therapy, marking a pivotal moment for th...
Rhodes
FDA Approves MORPHINE SULFATE EXTENDED RELEASE — Rhodes Pharmaceuticals LLC
Rhodes Pharmaceuticals announced the FDA approval of its Morphine Sulfate Extended Release tablets, adding a high-volume product to its generic portfo...
Rhodes
FDA Approves MORPHINE SULFATE EXTENDED RELEASE — Rhodes Pharmaceuticals LLC
Rhodes Pharmaceuticals LLC obtained FDA clearance to market Morphine Sulfate Extended Release, a generic entry poised to capture market share from the...
Acertis
FDA Approves PROMETRIUM — Acertis Pharmaceuticals, LLC
# FDA Approves Progesterone Oral Formulation for Acertis Pharmaceuticals Acertis Pharmaceuticals, LLC has received FDA approval for PROMETRIUM (proge...
Allergan,
FDA Approves ACTONEL — Allergan, Inc.
# FDA Approves Allergan's ACTONEL (Risedronate Sodium) for Oral Administration Allergan, Inc. has received FDA approval for ACTONEL (risedronate sodi...