Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA090572 for Children’s Cetirizine Oral Solutions
FDA approved ANDA090572 submitted by Tris Pharma, covering two discontinued children’s cetirizine hydrochloride oral solutions for allergy and hives relief.
Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
Cipla’s ABACAVIR SULFATE Oral Solution Receives Tentative FDA Approval (ANDA 078348)
The FDA has granted a tentative approval for Cipla Limited’s ABACAVIR SULFATE oral solution (20 mg) under ANDA 078348.
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Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
FDA Lists ANDA076458 for Fluoxetine Hydrochloride Oral Solution (Discontinued)
The FDA database shows ANDA076458 for fluoxetine hydrochloride oral solution, marketed under the brand Fluoxetine, with a discontinued status and multiple labeling submissions.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
FDA Approves Methylphenidate Hydrochloride Oral Solution (ANDA 207417)
FDA has approved ANDA 207417 for methylphenidate hydrochloride oral solution, 5 mg/5 mL and 10 mg/5 mL strengths, manufactured by Ascent Pharmaceuticals.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA207047 for Clindamycin Palmitate Hydrochloride
The FDA has approved ANDA207047 for an oral clindamycin palmitate hydrochloride solution (75 mg/5 ml) marketed by Heritage Pharmaceuticals under sponsor APPCO.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
FDA Approves Levetiracetam Oral Solution (ANDA078976)
FDA has approved ANDA078976 for Levetiracetam oral solution, a prescription drug manufactured by Actavis Pharma, Inc., with a detailed submission history.