Application 214408

Type: NDA
Sponsor: ACCORD HLTHCARE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEMETREXED	PEMETREXED	SOLUTION;INTRAVENOUS	100MG/4ML (25MG/ML),	No	No
002	PEMETREXED	PEMETREXED	SOLUTION;INTRAVENOUS	500MG/20ML (25MG/ML)	No	No
003	PEMETREXED	PEMETREXED	SOLUTION;INTRAVENOUS	850MG/34ML (25MG/ML)	No	No
004	PEMETREXED	PEMETREXED	SOLUTION;INTRAVENOUS	1000MG/40ML (25MG/ML).	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214408-001	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19
N214408-002	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19
N214408-003	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19
N214408-004	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19

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 3 · 116 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`5bbf6a4d5a75…`

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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pemetrexed	PEMETREXED DISODIUM	BluePoint Laboratories	14974d4e-2f01-4e02-aea2-c28b3ca0781c	2023-04-26	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED DISODIUM	Meitheal Pharmaceuticals Inc.	b185f459-5489-4e18-8521-1686b5d16f67	2022-12-21	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED DISODIUM	BluePoint Laboratories	c9f34c00-1176-4f44-8cff-bae5bdc0c40f	2022-12-08	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED	Teva Pharmaceuticals, Inc.	8b660f68-b770-4e0a-b2f9-25e663deecc3	2022-12-01	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed generic name: PEMETREXED
pemetrexed	PEMETREXED DISODIUM	Zydus Pharmaceuticals USA Inc.	363665ca-db15-4123-84ac-0ae66b5f1363	2022-05-26	Warnings, Adverse reactions	Name fallback brand name: pemetrexed
pemetrexed	PEMETREXED DISODIUM	Zydus Lifesciences Limited	6986de29-b077-48ac-ad2b-0cc478f72d89	2022-05-26		Name fallback brand name: pemetrexed
Pemetrexed	PEMETREXED DISODIUM	Qilu Pharmaceutical Co., Ltd.	46a9b89d-7135-4e0c-b8e4-52580554769b	2021-08-13	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
16729-522	Pemetrexed	Pemetrexed disodium	Accord Healthcare Inc.	NDA	Current
16729-522	Pemetrexed	Pemetrexed disodium	Accord Healthcare Inc.	NDA	Current
68001-550	Pemetrexed	Pemetrexed disodium	BluePoint Laboratories	NDA	Current
68001-551	Pemetrexed	Pemetrexed disodium	BluePoint Laboratories	NDA	Current
68001-552	Pemetrexed	Pemetrexed disodium	BluePoint Laboratories	NDA	Current
68001-553	Pemetrexed	Pemetrexed disodium	BluePoint Laboratories	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80869	SUPPL	2025-01-17
75777	SUPPL	2023-10-16
75735	SUPPL	2023-10-16
74348	ORIG	2023-05-23
71615	ORIG	2022-07-21
71093	ORIG	2022-05-18