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 oral pain medication. This app…
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Par Health USA, LLC received FDA approval for the ANDA 040330 to market ENDOCET (oxycodone hydrochloride and acetaminophen), a generic option for the oral pain medication. This app…
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 short-acting opioid market th…
# FDA Approves ASPEN's New Drug Application The FDA approved ASPEN's new drug application (NDA020992) on March 24, 1999, expanding the pharmaceutical manufacturer's product portfo…
FDA approval of ANI PHARMS' ANDA075327 authorizes the commercial launch of the generic version of the prescription substance, positioning the company to capture immediate market sh…
Haleon US Holdings LLC has received FDA approval for the expanded pediatric indication of Junior Strength Advil (ibuprofen), a reformulation of the generic product formerly known a…
# FDA Approves Generic Drug Application for Strides Pharma International Strides Pharma International received FDA approval for ANDA 040191 on December 17, 1998, marking the compa…
STRIDES PHARMA INTL secured FDA approval for its generic product via ANDA075295, a regulatory milestone expected to bolster its portfolio and generate revenue opportunities within …
# FDA Approves Janssen Pharmaceuticals' TOPAMAX (Topiramate) for Oral Use Janssen Pharmaceuticals, Inc. received FDA approval for TOPAMAX (topiramate) oral formulation on October …
Genentech, Inc. announced the approval of CELLCEPT (mycophenolate mofetil) oral suspension, providing clinicians with a critical liquid formulation to treat severe immunosuppressio…
# FDA Approves Fresenius Kabi's Intravenous Fluorouracil Formulation Fresenius Kabi USA, LLC received FDA approval for its intravenous fluorouracil formulation (ANDA040278), expan…
# FDA Approves Genentech's Herceptin for HER2-Positive Breast Cancer Genentech's HERCEPTIN (trastuzumab), the first monoclonal antibody approved for cancer treatment, has received…
Amneal Pharmaceuticals’ recent FDA approval for the generic version of butalbital/aspirin/caffeine/codeine phosphate positions the company to capture market share now that the bran…
# FDA Approves NorthStar Rx LLC's Labetalol Hydrochloride for Oral Administration NorthStar Rx LLC has received FDA approval for its generic labetalol hydrochloride oral formulati…
SUN PHARM INDUSTRIES announced FDA approval for ANDA040260, securing a regulatory milestone that adds a new generic option to its portfolio and positions the company to capture mar…
Celgene Corporation rallied on July 16, 1998, following the FDA's approval of its oral Thalomid (thalidomide) therapy, marking a pivotal moment for the drug maker that market analy…
Rhodes Pharmaceuticals announced the FDA approval of its Morphine Sulfate Extended Release tablets, adding a high-volume product to its generic portfolio. This clearance positions …
Rhodes Pharmaceuticals LLC obtained FDA clearance to market Morphine Sulfate Extended Release, a generic entry poised to capture market share from the leading oral morphine product…
# FDA Approves Progesterone Oral Formulation for Acertis Pharmaceuticals Acertis Pharmaceuticals, LLC has received FDA approval for PROMETRIUM (progesterone oral capsules), expand…
# FDA Approves Allergan's ACTONEL (Risedronate Sodium) for Oral Administration Allergan, Inc. has received FDA approval for ACTONEL (risedronate sodium hemipentahydrate), an oral …
ANI PHARMS has announced the successful approval of its ANDA filing, enabling the company to capitalize on forecasted market opportunities in the generic sector. The green light pr…