Application 207352

Type: ANDA
Sponsor: NANG KUANG PHARM CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEMETREXED DISODIUM	PEMETREXED DISODIUM	POWDER;INTRAVENOUS	EQ 100MG BASE/VIAL	No	No
002	PEMETREXED DISODIUM	PEMETREXED DISODIUM	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
A207352-001	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25
A207352-002	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
A207352-001	AP
A207352-002	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	A207352-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207352-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207352-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207352-002	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	A207352-001	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	A207352-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207352-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207352-002	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	A207352-001	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	A207352-002	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	A207352-001	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	A207352-002	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	A207352-001	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	A207352-002	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	A207352-001	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	A207352-002	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	A207352-001	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	A207352-002	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	A207352-001	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	A207352-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207352-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207352-002	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	A207352-001	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	A207352-002	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	A207352-001	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	A207352-002	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	A207352-001	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	A207352-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207352-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207352-002	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	A207352-001	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	A207352-002	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	A207352-001	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	A207352-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207352-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207352-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207352-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207352-002	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	A207352-001	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	A207352-002	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	A207352-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207352-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207352-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207352-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207352-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207352-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207352-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207352-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207352-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207352-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207352-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207352-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207352-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207352-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207352-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207352-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207352-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207352-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207352-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207352-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207352-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207352-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207352-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207352-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207352-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207352-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207352-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207352-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207352-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207352-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207352-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207352-002	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207352-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207352-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207352-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207352-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207352-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207352-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207352-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207352-002	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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pemetrexed	PEMETREXED DISODIUM	Sandoz Inc.	7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3	2025-12-16	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	Meitheal Pharmaceuticals Inc.	e0d000a3-b9d2-4fa9-9591-f7acb077481d	2025-11-17	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	Fresenius Kabi USA, LLC	ae77f00f-d43b-4b75-afd5-a2a9cb7138da	2025-08-31	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
PEMRYDI RTU	PEMETREXED DISODIUM	Amneal Pharmaceuticals LLC	0f006b06-ab85-423d-ba0c-dfc3fc25844e	2025-07-08	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	Somerset Therapeutics LLC	39219e4b-80a6-4d4f-96a3-1202e542d050	2025-05-10	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	Camber Pharmaceuticals, Inc.	2ca1ce75-5284-4282-b76a-3700d203c714	2025-04-01	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	Shilpa Medicare Limited	fe432994-e61b-4a87-8c98-cc20b847d0fe	2024-11-28	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	Sagent Pharmaceuticals	fa8f1f52-3f05-4ae8-bfec-7f0a029e6825	2024-09-30	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	NorthStar RxLLC	64f4a9ed-26ff-4bc7-bef1-4faa98b35563	2024-09-10	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	Meitheal Pharmaceuticals Inc.	1ceacc3e-f555-489b-8b16-2baa58b2f5a5	2024-04-19	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	Meitheal Pharmaceuticals Inc.	5fb3a2d5-b9ec-4044-abb9-3e0d848a448e	2024-04-19	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	Waverley Pharma Inc	95633c32-89a8-4275-94e7-939c9f2e6135	2023-12-30	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	BluePoint Laboratories	4cc1574b-3d2f-489b-9ad3-55695bb97200	2023-10-10	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Alimta	PEMETREXED DISODIUM	Eli Lilly and Company	f5a860f3-37ec-429c-ae04-9c88d7c55c08	2023-05-19	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	BluePoint Laboratories	61588f3c-4c06-4c35-a000-201dd1019093	2023-04-26	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	BluePoint Laboratories	14974d4e-2f01-4e02-aea2-c28b3ca0781c	2023-04-26	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	Meitheal Pharmaceuticals Inc.	b185f459-5489-4e18-8521-1686b5d16f67	2022-12-21	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed	PEMETREXED DISODIUM	BluePoint Laboratories	c9f34c00-1176-4f44-8cff-bae5bdc0c40f	2022-12-08	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM
Pemetrexed disodium	PEMETREXED DISODIUM	Dr. Reddys Laboratories Inc	1d8bcf03-e055-a274-7844-ae9a523e3c4c	2022-09-30	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed disodium generic name: PEMETREXED DISODIUM
pemetrexed	PEMETREXED DISODIUM	Zydus Pharmaceuticals USA Inc.	363665ca-db15-4123-84ac-0ae66b5f1363	2022-05-26	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED DISODIUM

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
70860-202	Pemetrexed	pemetrexed disodium	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-202	Pemetrexed	pemetrexed disodium	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-202	Pemetrexed	pemetrexed disodium	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-203	Pemetrexed	pemetrexed disodium	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-203	Pemetrexed	pemetrexed disodium	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-203	Pemetrexed	pemetrexed disodium	Athenex Pharmaceutical Division, LLC.	ANDA	Current