Watson Pharmaceuticals (now Actavis) received final approval from the U.S. FDA for Abbreviated New Drug Application (ANDA) 075961 on January 25, 2002....
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# FDA Approves VABRINTY (Leuprolide Acetate) for Subcutaneous Administration Uronova Pharmaceuticals, Inc. received FDA approval for VABRINTY (leupro...
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 re...
LGM Pharma Solutions, LLC (LGM) obtained FDA approval today for ORAL Ascomp with Codeine tablets (generic butalbital, aspirin, caffeine, and codeine p...
# FDA Approves Amphetamine Combination Formulation for Prasco Laboratories Prasco Laboratories received FDA approval for its oral amphetamine combina...
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 bra...
RISING announced today that the FDA has approved its ANDA, a regulatory milestone that the company expects will bolster its financial performance and ...
**USAntibiotics, LLC** has secured FDA clearance for Augmentin ES-600 (amoxicillin and clavulanate potassium), reinforcing the company's position in t...
SpecGx LLC has secured an FDA approval for the generic version of Acetaminophen and Codeine Phosphate oral tablets, expected to expand its current por...
# FDA Approves Teva Women's Health's Oral Methotrexate Sodium Product Teva Women's Health LLC received FDA approval for TREXALL (methotrexate sodium)...
On December 19, 2000, Rising received FDA approval for ANDA075725, marking a significant commercial entry into the market. This approval is expected t...
# FDA Approves Doxycycline ANDA for Strides Pharma Science Limited Strides Pharma Science Limited has received FDA approval for its abbreviated new d...
# FDA Approval Newswire Kenvue Brands LLC has received FDA approval for IMODIUM Multi-Symptom Relief, an oral combination formulation of loperamide h...
# FDA Approves Fresenius Medical Care's Venofer for Intravenous Iron Supplementation Fresenius Medical Care Holdings, Inc. received FDA approval for ...
# FDA Approves Generic Leuprolide Acetate for Meitheal Pharmaceuticals Meitheal Pharmaceuticals Inc received FDA approval for its generic leuprolide ...
Aurobindo Pharma Limited announced the approval of an Abbreviated New Drug Application for doxazosin mesylate tablets to be marketed immediately. This...
Advagen Pharma Ltd obtained FDA approval on October 6, 2000, for its generic oral Clonazepam tablet under ANDA075468. The clearance is expected to bol...
SpecGx LLC secured FDA approval for filing ANDA040405, gaining market access for generic HYDROCODONE BITARTRATE AND ACETAMINOPHEN. The entry of this g...
AbbVie Inc. solidified its foothold in the anticonvulsant market with the FDA approval of DEPAKOTE ER, the once-daily extended-release version of diva...
# FDA Approves Haleon's ABREVA (Docosanol) for Cold Sore Treatment Haleon US Holdings LLC has received FDA approval for ABREVA (docosanol), a topical...