Glenmark's generic nintedanib esylate capsules (ANDA212555) listed as approved, with July 2021 appro
FDA's Drugs@FDA database shows Glenmark Pharmaceuticals' generic nintedanib esylate ANDA carrying approved status, with an approval letter dated July 2021.
Glenmark's abbreviated new drug application for nintedanib esylate appears in FDA records with a standard review and an approval letter on file.
- Nintedanib esylate capsules, ANDA212555, sponsored by Glenmark Pharms Ltd, are listed with an original submission status marked as approved, with an application approval letter dated July 7, 2021.1 The product is available in two strengths, 150 mg and 100 mg base, as oral capsules under the brand name Nintedanib Esylate.1
Fact check notes
- Imprecise
FDA's Drugs@FDA database shows Glenmark Pharmaceuticals' generic nintedanib esylate ANDA carrying approved status
Source lists sponsor as 'GLENMARK PHARMS LTD', not the expanded 'Glenmark Pharmaceuticals'; likely the same company but the full name isn't what's in the record. - Checker's noteThe summary paragraph expands the sponsor name to 'Glenmark Pharmaceuticals' while the source record lists it as 'GLENMARK PHARMS LTD'; the bullet point correctly uses 'Glenmark Pharms Ltd', creating an inconsistency.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Where the check questioned a sentence, its note is shown above. Not investment advice.