Regulatorische Updates
8. Sept. 2026•1 Min. Lesezeit
FDA Approves Sandoz ANDA076873 for Metformin Hydrochloride Extended‑Release Tablet
The FDA has approved Sandoz's ANDA076873 for a prescription oral metformin hydrochloride 500 mg extended‑release tablet, with multiple labeling supplements approved.
Regulatorische Updates
5. Sept. 2026•1 Min. Lesezeit
FDA Approves Manufacturing and Labeling for Propoxyphe ne Hydrochloride 65 mg Oral Capsules
FDA has approved multiple manufacturing (CMC) and labeling submissions for the oral 65 mg Propoxyphe ne Hydrochloride capsule, now listed as discontinued.
Regulatorische Updates
5. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA 077395 for Paroxetine Hydrochloride Oral Suspension (Discontinued)
The FDA approved ANDA 077395 for an oral suspension of Paroxetine Hydrochloride; the product is listed as discontinued and has a series of labeling supplement approvals.
Regulatorische Updates
5. Sept. 2026•1 Min. Lesezeit
Quinapril Hydrochloride and Hydrochlorothiazide Tablets – FDA Labeling Approvals (ANDA 077093)
FDA records show labeling approvals for discontinued quinapril/hydrochlorothiazide tablets across multiple supplemental applications from 2011 to 2022.
Regulatorische Updates
5. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA 076802 for Glimepiride Tablets (Discontinued)
FDA approved ANDA 076802 for oral glimepiride tablets in 1 mg, 2 mg and 4 mg strengths; all listed as discontinued after multiple labeling supplements.
Regulatorische Updates
5. Sept. 2026•1 Min. Lesezeit
FDA Approves Labeling Updates for Discontinued Fenofibrate Tablet Products (ANDA 076520)
The FDA has approved a series of labeling submissions for three discontinued oral fenofibrate tablet products (54 mg, 107 mg, 160 mg) under ANDA 076520, with approvals spanning 2005‑2021.
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
FDA Approves Multiple Labeling Updates for Levetiracetam Oral Solution
The FDA has approved several labeling supplement submissions for the discontinued oral solution Levetiracetam (100 mg/mL) spanning from 2011 to 2024.
Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
DICOPAC KIT
FDA NDA017406 for DICOPAC KIT, sponsored by GE Healthcare, indicates the product is discontinued and lists its submission history and active ingredients.
Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
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.
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
3. Sept. 2026•1 Min. Lesezeit
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.