Regulatory Updates
Sep 18, 2026•1 min read
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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Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants Tentative Approval for Dapagliflozin Tablets (ANDA219408)
Sciegen Pharmaceuticals received tentative FDA approval for 5 mg and 10 mg dapagliflozin tablets under ANDA219408.
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Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Jubilant Itraconazole 100 mg Capsule (ANDA203445)
FDA approved labeling for Jubilant Generics' oral itraconazole 100 mg capsule (ANDA203445); the product is listed as discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
FDA ANDA202002: Strides Pharma Submits Original Application for IMIQUIMOD 5% Cream
Strides Pharma filed ANDA202002 for a 5% IMIQUIMOD topical cream (product 001). The original submission was listed as approved on 24‑Jun‑2014.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA078102 for Meloxicam Oral Tablets
FDA approved application ANDA078102 submitted by TARO for meloxicam tablets (7.5 mg and 15 mg). Both products are listed with discontinued marketing status.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Discontinues Oral CHLORPHENIRAMINE MALEATE Tablet (ANDA080786)
The FDA has marked the oral CHLORPHENIRAMINE MALEATE 4 mg tablet (product 001) from sponsor PVT FORM as discontinued under ANDA080786.
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Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves PHYTONADIONE (Vitamin K) Generic – ANDA213336
FDA granted approval for PHYTONADIONE tablets, a vitamin K generic from Agnitio Inc., under ANDA213336 on Oct 12, 2023.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves Sevelamer Hydrochloride Generic (ANDA 206883) by Macleods Pharmaceuticals
The FDA has approved the generic drug Sevelamer Hydrochloride (ANDA 206883) from Macleods Pharmaceuticals, available as 400 mg and 800 mg oral tablets.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Discontinues Oral Prednisolone Tablet (ANDA083675)
The FDA has listed the oral prednisolone 5 mg tablet (product 001) from sponsor Bundy as discontinued under ANDA083675.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANDA078384 for Carvedilol Tablets by Unichem Pharmaceuticals
The FDA has approved ANDA078384 for carvedilol oral tablets (3.125‑25 mg) manufactured by Unichem Pharmaceuticals and sponsored by Regcon Holdings.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Issues ANDA Approval for Watson Labs' Procaineamide Hydrochloride Oral Capsule (ANDA083795)
The FDA has approved an ANDA (ANDA083795) for Watson Labs' oral capsule containing 250 mg of procaineamide hydrochloride. The product is listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA080800 for Diphenhydramine Hydrochloride Oral Capsule
FDA granted approval for ANDA080800, a 50 mg diphenhydramine hydrochloride oral capsule submitted by Whiteworth Town Plsn; the product is listed as discontinued.