Application 213222

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ICATIBANT ACETATE	ICATIBANT ACETATE	INJECTABLE;SUBCUTANEOUS	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213222-001	ICATIBANT ACETATE	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS			2021-05-21

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
2026-02-19 14:30 UTC	2026-02	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-05-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-05-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-05-21	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-05-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-05-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2021-05-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213222-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2021-05-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213222-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213222-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213222-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213222-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213222-001	AP	1	`782e0a99824c…`
2022-10-28 04:53 UTC	2022-10	A213222-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213222-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213222-001	AP	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Firazyr	ICATIBANT ACETATE	Takeda Pharmaceuticals America, Inc.	ed6657ca-ab68-477a-9968-e12dc928b540	2025-07-07	Warnings, Adverse reactions	Name fallback generic name: ICATIBANT ACETATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68462-828	Icatibant	icatibant acetate	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-828	Icatibant	icatibant acetate	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current