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# FDA Approves Zydus Pharmaceuticals' Generic Diltiazem Hydrochloride Zydus Pharmaceuticals (USA) Inc. received FDA approval for its generic diltiaze...
Hikma announced FDA approval for its ANDA 208795, a regulatory milestone expected to bolster the company’s commercial pipeline and drive future revenu...
On July 21, 2017, the FDA approved OxyCODONE HYDROCHLORIDE tablets under ANDA No. 208593, granting manufacturer KVK-Tech, Inc. immediate access to the...
Janssen Biotech announced today that the FDA has approved GUSELKUMAB (TREMFYA), a subcutaneous anti-IL-23r antibody, following a standard six-week rev...
# FDA Approves Generic Drug Application for Hikma Pharmaceuticals Hikma Pharmaceuticals received FDA approval for ANDA 208809 on July 6, 2017, expand...
Amneal Pharmaceuticals announced FDA approval of its Abbreviated New Drug Application number ANDA206869 on June 23, 2017, subjecting the drug to signi...
# FDA Approves Generic Drug Application for Actavis Labs FL Inc Actavis Labs FL Inc received FDA approval for ANDA207139 on June 20, 2017, positionin...
1. **Analyze the Request:** * **Topic:** FDA drug approval. * **Input Data:** * Brand: N/A * Generic: N/A * ...
Lannett Co. Inc. has received FDA approval for ANDA 207171, which is expected to bolster its generic portfolio and contribute incremental revenue as t...
Lupin Pharmaceuticals, Inc. received FDA approval for its Oxycodone Hydrochloride generic on June 12, 2017, securing a position in the competitive opi...
# FDA Approves Generic Drug Application for Sagent Pharmaceuticals Sagent Pharmaceuticals Inc. received FDA approval for ANDA 203608 on May 11, 2017,...
Novartis has secured FDA approval for the co-packaged fixed-dose combination of KISQALI and Femara (ribociclib and letrozole), a strategic move aimed ...
# FDA Approves AstraZeneca's IMFINZI (Durvalumab) for Cancer Treatment AstraZeneca Pharmaceuticals LP has received FDA approval for IMFINZI (durvalum...
# FDA Approves Rising's Generic Drug Application The FDA approved ANDA200542 for Rising Pharmaceuticals on April 28, 2017, expanding the company's ge...
On April 28, the FDA approved a generic version of the nasal spray AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE manufactured by Apotex Corp., r...
# FDA Approves Azurity Pharmaceuticals' XATMEP Oral Methotrexate Formulation Azurity Pharmaceuticals has received FDA approval for XATMEP (methotrexa...
Protega Pharmaceuticals Inc. has received FDA approval for Roxycbond (oxycodone hydrochloride), a crucial strategic addition for the company intended ...
# FDA Approves Piroxicam Generic for Unichem Pharmaceuticals Unichem Pharmaceuticals (USA), Inc. received FDA approval for its generic piroxicam oral...
# FDA Approves Rising Pharmaceuticals' Generic Drug Application Rising Pharmaceuticals has received FDA approval for an abbreviated new drug applicat...
# FDA Approves Rising Pharmaceuticals' Generic Drug Application Rising Pharmaceuticals has received FDA approval for ANDA200217, expanding its generi...