Actualizaciones regulatorias
24 sept 2026•1 min de lectura
FDA Approves ANDA210245 for Pomalidomide Oral Capsules
The FDA has approved ANDA210245 submitted by MSN for generic pomalidomide capsules in 2 mg, 3 mg, and 4 mg strengths.
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Actualizaciones regulatorias
23 sept 2026•1 min de lectura
FDA Approves Apotex Nizatidine Capsule ANDA 076383
FDA approved ANDA 076383 for Apotex Inc.'s oral Nizatidine capsules (150 mg and 300 mg) on Jan 23 2003; both products are listed as discontinued.
Actualizaciones regulatorias
8 sept 2026•1 min de lectura
FDA Approves ANDA080807 for Diphenhydramine Capsules – IMPAX Labs
FDA approved ANDA080807 submitted by IMPAX Labs for oral diphenhydramine hydrochloride capsules (25 mg and 50 mg). Both products are listed as discontinued.
Actualizaciones regulatorias
31 ago 2026•1 min de lectura
FDA Approves Ranbaxy Ramipril Capsules (ANDA078849)
FDA approves ANDA078849 submitted by Ranbaxy Labs Ltd for oral ramipril 5 mg and 10 mg capsules, both listed as discontinued.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
FDA ANDA083061: Diphenhydramine Hydrochloride Capsules Discontinued
FDA ANDA083061 lists two oral diphenhydramine hydrochloride capsule products (25 mg and 50 mg) from Perrigo, both marked discontinued.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
WHARTON LABS ANDA083665: Oral Vitamin A Capsule Discontinued
WHARTON LABS submitted ANDA083665 for an oral Vitamin A capsule containing vitamin A palmitate (50,000 units). The product is listed as discontinued.