Application 208696

Type: ANDA
Sponsor: JIANGSU HANSOH PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEMETREXED	PEMETREXED	POWDER;INTRAVENOUS	EQ 100MG BASE/VIAL	No	No
002	PEMETREXED	PEMETREXED	POWDER;INTRAVENOUS	EQ 500MG BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A208696-001	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25
A208696-002	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208696-001	AP
A208696-002	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 · 60 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
2026-08-18 06:07:40	2026-07	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208696-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208696-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208696-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208696-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208696-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208696-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208696-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208696-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208696-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208696-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208696-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208696-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208696-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208696-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208696-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208696-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208696-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208696-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208696-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208696-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208696-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208696-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208696-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208696-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208696-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208696-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208696-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208696-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208696-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208696-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208696-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208696-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208696-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208696-002	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208696-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208696-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208696-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208696-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208696-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208696-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208696-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208696-002	AP	1	`a72a2bbeb626…`

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
Pemetrexed	PEMETREXED DISODIUM	Meitheal Pharmaceuticals Inc.	e0d000a3-b9d2-4fa9-9591-f7acb077481d	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208696 application number: ANDA208696 ndc (product): 71288-167 ndc (product): 71288-166
Pemetrexed	PEMETREXED DISODIUM	NorthStar RxLLC	64f4a9ed-26ff-4bc7-bef1-4faa98b35563	2024-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208696 application number: ANDA208696
Pemetrexed	PEMETREXED DISODIUM	Meitheal Pharmaceuticals Inc.	1ceacc3e-f555-489b-8b16-2baa58b2f5a5	2024-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208696 application number: ANDA208696 ndc (product): 71288-167 ndc (product): 71288-166
Pemetrexed	PEMETREXED DISODIUM	Meitheal Pharmaceuticals Inc.	5fb3a2d5-b9ec-4044-abb9-3e0d848a448e	2024-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208696 application number: ANDA208696 ndc (product): 71288-167 ndc (product): 71288-166

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
71288-166	Pemetrexed	Pemetrexed disodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-166	Pemetrexed	Pemetrexed disodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-166	Pemetrexed	Pemetrexed disodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-167	Pemetrexed	Pemetrexed disodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-167	Pemetrexed	Pemetrexed disodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-167	Pemetrexed	Pemetrexed disodium	Meitheal Pharmaceuticals Inc.	ANDA	Current