Application 212446

Type: ANDA
Sponsor: CIPLA

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 42.

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
A212446-001	ICATIBANT ACETATE	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP		2020-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212446-001	AP

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
2026-08-18 06:07:40	2026-07	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212446-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-07-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212446-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212446-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212446-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212446-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212446-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212446-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212446-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212446-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212446-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212446-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212446-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212446-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212446-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212446-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212446-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212446-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212446-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212446-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212446-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212446-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212446-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212446-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212446-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212446-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212446-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212446-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212446-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212446-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212446-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212446-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212446-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212446-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212446-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212446-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212446-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212446-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212446-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212446-001	AP	1	`a50c72e98297…`

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
ICATIBANT	ICATIBANT	Cipla USA Inc.	ccbb5e50-ce56-4898-aa1a-f1c1f3d312f6	2024-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212446 application number: ANDA212446 ndc (product): 69097-664
SAJAZIR	ICATIBANT	Cycle Pharmaceuticals Ltd-Uk	1756aca0-21a1-4898-8d6c-9666738db45c	2024-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212446 application number: ANDA212446 ndc (product): 70709-013

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-664	ICATIBANT	ICATIBANT	Cipla USA Inc.	ANDA	Current
69097-664	ICATIBANT	ICATIBANT	Cipla USA Inc.	ANDA	Current
69097-664	ICATIBANT	ICATIBANT	Cipla USA Inc.	ANDA	Current
70709-013	SAJAZIR	ICATIBANT	Cycle Pharmaceuticals Ltd-Uk	ANDA	Current
70709-013	ICATIBANT	ICATIBANT	Cycle Pharmaceuticals Ltd-Uk	ANDA	Current
70709-013	SAJAZIR	ICATIBANT	Cycle Pharmaceuticals Ltd-Uk	ANDA	Current