Regulatory Updates
Sep 3, 2026•1 min read
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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Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Multiple Simvastatin Tablet Labeling Submissions (ANDA 077752)
The FDA has approved several labeling submissions for generic oral Simvastatin tablets (5‑80 mg) under ANDA 077752, confirming their prescription status.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Fresenius Kabi’s OCTREOTIDE Acetate Injectable (ANDA 077457)
The FDA has granted approval for Fresenius Kabi USA’s preservative‑free OCTREOTIDE acetate injectable products under ANDA 077457, covering three dosage strengths for injection.
Regulatory Updates
Sep 3, 2026•1 min read
Woodward’s Milrinone Lactate Injection Products Discontinued – ANDA077151
FDA records show two Woodward Milrinone Lactate injectable products are listed as discontinued under ANDA077151.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA084712 for Bethanechol Chloride Tablet (10 mg) – Lannett
The FDA has approved ANDA084712 for Bethanechol Chloride 10 mg tablets, marketed by Lannett, now listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Actavis Labs Metoprolol Succinate Extended‑Release Tablets (ANDA 076862)
Actavis Labs FL Inc received FDA approval for its metoprolol succinate extended‑release tablets under ANDA 076862, covering a prescription 50 mg product and a discontinued 25 mg product.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA 076576 for Sotalol Hydrochloride Tablets by Sun Pharm Industries
The FDA approved application ANDA076576 for oral Sotalol Hydrochloride tablets (80 mg, 120 mg, 160 mg) from Sun Pharm Industries; all listed products are marked discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
DICOPAC KIT
FDA NDA017406 for DICOPAC KIT, sponsored by GE Healthcare, indicates the product is discontinued and lists its submission history and active ingredients.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Cipla Cetirizine Allergy Tablets (ANDA077318)
FDA has approved Cipla Ltd.'s ANDA077318 for two oral cetirizine hydrochloride allergy tablets (5 mg and 10 mg), both listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ECONOPRED Ophthalmic Suspension (NDA 017468) – Discontinued
The FDA approved ECONOPRED, a 0.125% prednisolone acetate ophthalmic suspension, under NDA 017468 with multiple manufacturing submissions and a 2003 labeling approval. The product is now listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
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.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Records Show Discontinued AMINOPHYLLIN Tablet Products and Historical Submissions
The FDA database lists two discontinued oral tablet products named AMINOPHYLLIN (100 mg and 200 mg) and documents multiple labeling and manufacturing submissions approved between 1977 and 1991.