Actualités réglementaires
19 sept. 2026•1 min de lecture
FDA Approves Lupin Losartan Potassium/Hydrochlorothiazide Combination (ANDA078245)
FDA has approved an ANDA for Lupin's prescription oral tablets combining losartan potassium and hydrochlorothiazide, available in multiple strengths.
Actualités réglementaires
18 sept. 2026•1 min de lecture
Lupin Ltd Submits Original ANDA216716 to FDA – Tentative Approval
Lupin Ltd filed an original ANDA (application number ANDA216716) with the FDA, currently listed as Tentative Approval as of August 13, 2024.
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Actualités réglementaires
17 sept. 2026•1 min de lecture
FDA Approves Lupin Pharmaceuticals' FYAVOLV (Norethindrone Acetate/Ethinyl Estradiol)
The FDA has approved ANDA204213 for FYAVOLV, a prescription oral tablet combining norethindrone acetate and ethinyl estradiol, manufactured by Lupin Pharmaceuticals.
Actualités réglementaires
11 sept. 2026•1 min de lecture
FDA Approves Lupin’s DOXERCALCIFEROL Injection (ANDA210801)
The FDA approved Lupin’s injectable DOXERCALCIFEROL (4 mcg/2 ml) under ANDA210801; the product is listed as discontinued.
Actualités réglementaires
9 sept. 2026•1 min de lecture
FDA Approves Lupin Generic Levetiracetam Tablets (ANDA 078154)
The FDA has approved Lupin Pharmaceuticals’ generic levetiracetam tablets in 250 mg, 500 mg, and 750 mg oral strengths under ANDA 078154.
Actualités réglementaires
3 sept. 2026•1 min de lecture
FDA Approves Lupin ANDA209272 for Metoprolol Succinate ER Tablets
FDA approved Lupin's ANDA209272 for metoprolol succinate extended‑release tablets in four strengths, all currently listed as discontinued.
Actualités réglementaires
2 sept. 2026•1 min de lecture
FDA Approves Lupin’s CYANOCOBALAMIN Nasal Spray
The FDA granted approval for Lupin Pharmaceuticals' prescription nasal spray containing 0.5 mg per spray of CYANOCOBALAMIN under ANDA210629.
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