Regulatory Updates
Sep 25, 2026•1 min read
Bell Pharma’s Chlorpheniramine Maleate Tablet (ANDA083062) Listed as Discontinued
Bell Pharma’s oral tablet of chlorpheniramine maleate (4 mg) under ANDA083062 has been marked as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA078979 for DIVALPROEX SODIUM
The FDA has approved application ANDA078979 for the oral delayed‑release capsule of DIVALPROEX SODIUM, manufactured by NorthStar Rx LLC and Dr. Reddy's Laboratories Ltd.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Discontinues FOLEX Injectable Methotrexate Products (ANDA087695)
The FDA's ANDA087695 filing for FOLEX injectable methotrexate (25 mg, 50 mg, 100 mg) shows all three products are listed as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA 088371 for Baxter Cyclophosphamide Injection
The FDA has approved ANDA 088371 for a cyclophosphamide injectable product (100 mg/vial) marketed by Baxter Healthcare, with multiple manufacturing and labeling submissions approved.
Regulatory Updates
Sep 25, 2026•1 min read
FDA ANDA088048 Approval for Fluocinolone Acetonide Topical Solution (Discontinued)
The FDA’s ANDA088048 for a fluocinolone acetonide 0.01% topical solution submitted by Allied is listed as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA 077780 for Carvedilol Tablets by TARO
FDA issued an approval letter for ANDA 077780 covering carvedilol oral tablets (3.125 mg, 6.25 mg, 12.5 mg, 25 mg) submitted by TARO; all listed products are marked discontinued.
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Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Teva Generic FAMCICLOVIR (ANDA 077487) for Oral Use
The FDA has approved Teva Pharmaceuticals’ ANDA 077487 for the oral tablet formulation of FAMCICLOVIR, available in 125 mg, 250 mg and 500 mg strengths.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA 077179 for Amlodipine Besylate/Benazepril Hydrochloride Capsules (Discontinued)
The FDA’s ANDA 077179 approval covers oral capsule products of amlodipine besylate combined with benazepril hydrochloride, all listed as discontinued, with labeling submissions approved in 2011 and 2016.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA 076886 for Fosphenytoin Sodium Injection (DR REDDYS)
The FDA granted approval for ANDA 076886, a fosphenytoin sodium injection by DR REDDYS, now listed as discontinued. Original approval in 2007 with labeling updates in 2020.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Ranbaxy Gabapentin Tablet ANDA076605 (600 mg & 800 mg)
The FDA approved application ANDA076605 for Ranbaxy’s oral gabapentin tablets (600 mg and 800 mg). Both products are currently listed as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves SUN PHARM Fluconazole Oral Suspension ANDA 076332
FDA approved Sun Pharm Industries Ltd's ANDA 076332 for Fluconazole oral suspension (200 mg/5 mL and 50 mg/5 mL). Both products are now discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
Sandoz Secures Tentative FDA Approval for Generic Rosiglitazone Maleate Tablets (ANDA078674)
Sandoz's ANDA078674 for oral rosiglitazone maleate tablets (2 mg, 4 mg, 8 mg) has received tentative approval from the FDA as of March 9 2009.