Application 212555

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	NINTEDANIB	NINTEDANIB ESYLATE	CAPSULE;ORAL	EQ 150MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212555-001	NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2026-07-09
A212555-002	NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB		2026-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A212555-001	AB
A212555-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212555-001	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2026-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212555-002	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2026-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212555-001	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212555-002	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2026-07-09	`caaa826d4ba7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212555-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212555-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212555-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212555-002	AB	1	`caaa826d4ba7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nintedanib	NINTEDANIB	AvKARE	572722d7-338a-e4d2-e063-6394a90a257c	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212555 application number: ANDA212555
nintedanib	NINTEDANIB	Glenmark Pharmaceuticals Inc., USA	b14164fb-0276-4ad1-a5ff-400ab9e292da	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212555 application number: ANDA212555

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68025	ORIG	2021-07-07