Application 212993

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	INJECTABLE;INJECTION	40MG/2ML (20MG/ML)	No	No
002	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/5ML (20MG/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212993-001	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-11-18
A212993-002	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212993-001	AP
A212993-002	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.

Product history page 1 of 2 · 76 observed 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	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212993-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212993-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212993-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212993-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212993-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212993-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212993-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212993-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212993-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212993-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212993-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212993-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212993-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212993-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212993-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212993-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212993-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212993-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212993-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212993-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212993-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212993-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212993-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212993-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212993-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212993-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212993-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212993-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212993-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212993-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212993-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212993-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212993-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212993-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212993-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212993-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212993-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212993-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212993-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212993-002	AP	1	`87673890dc5c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irinotecan hydrochloide	IRINOTECAN HYDROCHLOIDE	Xiromed LLC	b26e5d27-dba5-7538-9e7b-48b358998cbb	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212993 application number: ANDA212993 ndc (product): 70700-170 ndc (product): 70700-169
Irinotecan hydrochloide	IRINOTECAN HYDROCHLOIDE	BluePoint Laboratories	b66dbd6d-6ccb-ce9d-e053-2995a90a4c3c	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212993 application number: ANDA212993 ndc (product): 68001-480
Irinotecan hydrochloride	IRINOTECAN HYDROCHLORIDE	Northstar Rx LLC	4f98e9ed-f7b1-5346-af72-fccb0abf3f4b	2022-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212993 application number: ANDA212993 ndc (product): 16714-131 ndc (product): 16714-027
Irinotecan hydrochloide	IRINOTECAN HYDROCHLOIDE	Gland Pharma Limited	de634e80-328a-4473-b395-0172683a2411	2022-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212993 application number: ANDA212993 ndc (product): 68083-382 ndc (product): 68083-381

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-027	Irinotecan hydrochloride	Irinotecan hydrochloride	Northstar Rx LLC	ANDA	Current
16714-027	Irinotecan hydrochloride	Irinotecan hydrochloride	Northstar Rx LLC	ANDA	Current
16714-027	Irinotecan hydrochloride	Irinotecan hydrochloride	Northstar Rx LLC	ANDA	Current
16714-131	Irinotecan hydrochloride	Irinotecan hydrochloride	Northstar Rx LLC	ANDA	Current
16714-131	Irinotecan hydrochloride	Irinotecan hydrochloride	Northstar Rx LLC	ANDA	Current
16714-131	Irinotecan hydrochloride	Irinotecan hydrochloride	Northstar Rx LLC	ANDA	Current
68001-480	Irinotecan hydrochloide	Irinotecan hydrochloide	BluePoint Laboratories	ANDA	Current
68001-480	Irinotecan hydrochloide	Irinotecan hydrochloide	BluePoint Laboratories	ANDA	Current
68001-480	Irinotecan hydrochloide	Irinotecan hydrochloide	BluePoint Laboratories	ANDA	Current
68001-480	Irinotecan hydrochloide	Irinotecan hydrochloide	BluePoint Laboratories	ANDA	Current
68001-480	Irinotecan hydrochloide	Irinotecan hydrochloide	BluePoint Laboratories	ANDA	Current
68083-381	Irinotecan hydrochloide	Irinotecan hydrochloide	Gland Pharma Limited	ANDA	Current
68083-381	Irinotecan hydrochloide	Irinotecan hydrochloide	Gland Pharma Limited	ANDA	Current
68083-381	Irinotecan hydrochloide	Irinotecan hydrochloide	Gland Pharma Limited	ANDA	Current
68083-381	Irinotecan hydrochloide	Irinotecan hydrochloide	Gland Pharma Limited	ANDA	Current
68083-382	Irinotecan hydrochloride	Irinotecan hydrochloride	Gland Pharma Limited	ANDA	Current
68083-382	Irinotecan hydrochloride	Irinotecan hydrochloride	Gland Pharma Limited	ANDA	Current
68083-382	Irinotecan hydrochloride	Irinotecan hydrochloride	Gland Pharma Limited	ANDA	Current
68083-382	Irinotecan hydrochloride	Irinotecan hydrochloride	Gland Pharma Limited	ANDA	Current
70700-169	Irinotecan hydrochloide	Irinotecan hydrochloide	Xiromed LLC	ANDA	Current
70700-169	Irinotecan hydrochloide	Irinotecan hydrochloide	Xiromed LLC	ANDA	Current
70700-169	Irinotecan hydrochloide	Irinotecan hydrochloide	Xiromed LLC	ANDA	Current
70700-170	Irinotecan hydrochloride	Irinotecan hydrochloride	Xiromed LLC	ANDA	Current
70700-170	Irinotecan hydrochloride	Irinotecan hydrochloride	Xiromed LLC	ANDA	Current
70700-170	Irinotecan hydrochloride	Irinotecan hydrochloride	Xiromed LLC	ANDA	Current