FDA Approves VALPROATE SODIUM — Sagent Pharmaceuticals
# FDA Approves Sagent Pharmaceuticals' Intravenous Valproate Sodium Formulation Sagent Pharmaceuticals has received FDA approval for its intravenous formulation of valproate sodiu…
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# FDA Approves Sagent Pharmaceuticals' Intravenous Valproate Sodium Formulation Sagent Pharmaceuticals has received FDA approval for its intravenous formulation of valproate sodiu…
USAntibiotics, LLC announced on Tuesday that the FDA has granted approval for AMOXICILLIN AND CLAVULANATE POTASSIUM, oral dosage form NDA050785, with a designated 180-day exclusivi…
SUN PHARM INDS INC announced today the receipt of FDA approval for the competition-friendly ANDA040446. This regulatory win is likely to bolster the company's generic portfolio and…
Uronova Pharmaceuticals announced the FDA approval of VABRINTY (Leuprolide Acetate) Subcutaneous for Autoinjector, continuing the company’s strategy of commercializing established …
Amneal Pharmaceuticals NY LLC announced the approval of its ANDA for tramadol hydrochloride oral tablet from the FDA, initiating commercialization of generic equivalents to the pai…
Teva Pharmaceuticals USA, Inc. received FDA approval for generic Tramadol Hydrochloride tablets, a development likely to intensify generic competition and pressure pricing within t…
SUN PHAR INDS INC announced its approval of ANDA075964 on June 19, 2002, but the absence of both brand and generic names alongside the route of administration renders the submissio…
# FDA Approves Roerig's VFEND (voriconazole) for Invasive Fungal Infections Roerig has received FDA approval for VFEND (voriconazole), an oral antifungal agent designed to treat s…
On April 23, 2002, Apotex announced approval for its abbreviated new drug application (ANDA075984), signaling its entry into the pharma market. This regulatory milestone gives the …
PHARMOBEDIENT received FDA approval for its ANDA on April 22, 2002, position the company to capture market share and increase competition within the relevant therapeutic segment.
Hikma Pharmaceuticals USA Inc. secured FDA approval for its generic nasal butorphanol tartrate product, reinforcing its strategic expansion within the pain management sector. This …
Lannett Company, Inc. leverages the regulatory milestone for its oral levothyroxine sodium formulation to secure a consistent market footprint in the generic thyroid hormone replac…
On February 21, 2002, Sun Pharm Industries announced the approval of generic drug application ANDA076038, subjecting the prescription to generic competition immediately. Investor f…
Watson Pharmaceuticals (now Actavis) received final approval from the U.S. FDA for Abbreviated New Drug Application (ANDA) 075961 on January 25, 2002. This clearance positions the …
PuraCap Laboratories LLC dba Blu Pharmaceuticals announced Wednesday the approval of its ANDA for Metformin Hydrochloride, a generic oral drug. This development underscores the sus…
# FDA Approves VABRINTY (Leuprolide Acetate) for Subcutaneous Administration Uronova Pharmaceuticals, Inc. received FDA approval for VABRINTY (leuprolide acetate) injection, expan…
Aurobindo Pharma USA has secured FDA approval to market a generic drug with ANDA 076152, moving the company to fulfill a specific market need. This regulatory milestone enhances Au…
LGM Pharma Solutions, LLC (LGM) obtained FDA approval today for ORAL Ascomp with Codeine tablets (generic butalbital, aspirin, caffeine, and codeine phosphate), a combination analg…
# FDA Approves Amphetamine Combination Formulation for Prasco Laboratories Prasco Laboratories received FDA approval for its oral amphetamine combination therapy on October 11, 20…
Kenvue Brands LLC secured a competitive edge in the oral allergy market with the 2001 FDA approval of ZYRTEC-D, allowing the company to leverage a branded combination of cetirizine…