Application 208746

Type: NDA
Sponsor: HOSPIRA INC

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
003	PEMETREXED	PEMETREXED	POWDER;INTRAVENOUS	EQ 1G BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N208746-001	PEMETREXED DITROMETHAMINE	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10
N208746-002	PEMETREXED DITROMETHAMINE	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10
N208746-003	PEMETREXED DITROMETHAMINE	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208746-001	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208746-002	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208746-003	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208746-001	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208746-002	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208746-003	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208746-001	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208746-002	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208746-003	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208746-001	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208746-002	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208746-003	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208746-001	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208746-002	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208746-003	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208746-001	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208746-002	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208746-003	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208746-001	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208746-002	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208746-003	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208746-001	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208746-002	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208746-003	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208746-001	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208746-002	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208746-003	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208746-001	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208746-002	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208746-003	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208746-001	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208746-002	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208746-003	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208746-001	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208746-002	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208746-003	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208746-001	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208746-002	PEMETREXED DITROMETHAMINE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208746-003	PEMETREXED DITROMETHAMINE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	RLD	2022-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208746-001	PEMETREXED DITROMETHAMINE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-06-10	`8072bd15b7f6…`

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 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pemfexy	PEMETREXED	Acacia Pharma, Ltd.	caef07ce-066b-4c48-98dc-974b05ebbbe0	2026-06-18	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED
Pemfexy	PEMETREXED	Eagle Pharmaceuticals, Inc.	2308f4e8-21c8-49c1-a5b8-deb8610bac6a	2026-02-20	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED
Pemetrexed	PEMETREXED	Solco Healthcare US, LLC	bd0ada98-3237-4465-8ba2-3a12c33116fb	2025-12-31	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed generic name: PEMETREXED
Pemetrexed	PEMETREXED DISODIUM	Sandoz Inc.	7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED DISODIUM	Meitheal Pharmaceuticals Inc.	e0d000a3-b9d2-4fa9-9591-f7acb077481d	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
PEMETREXED	PEMETREXED	Hospira, Inc.	3ae68628-7ab0-4491-b3ae-6a8330b719c8	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: PEMETREXED generic name: PEMETREXED
AXTLE	PEMETREXED	Avyxa Pharma, LLC	9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b1	2025-10-08	Warnings, Adverse reactions	Name fallback generic name: PEMETREXED
Pemetrexed	PEMETREXED DISODIUM	Fresenius Kabi USA, LLC	ae77f00f-d43b-4b75-afd5-a2a9cb7138da	2025-08-31	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED DISODIUM	Somerset Therapeutics LLC	39219e4b-80a6-4d4f-96a3-1202e542d050	2025-05-10	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED DISODIUM	Camber Pharmaceuticals, Inc.	2ca1ce75-5284-4282-b76a-3700d203c714	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED DISODIUM	Shilpa Medicare Limited	fe432994-e61b-4a87-8c98-cc20b847d0fe	2024-11-28	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED DISODIUM	Sagent Pharmaceuticals	fa8f1f52-3f05-4ae8-bfec-7f0a029e6825	2024-09-30	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED DISODIUM	NorthStar RxLLC	64f4a9ed-26ff-4bc7-bef1-4faa98b35563	2024-09-10	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
PEMETREXED	PEMETREXED	Hospira, Inc.	3e087418-69ff-47fa-93c2-f28699309433	2024-07-24	Warnings, Adverse reactions	Name fallback brand name: PEMETREXED generic name: PEMETREXED
PEMETREXED	PEMETREXED	Accord Healthcare Inc.	dfd19e67-54cb-c062-e053-2995a90a294a	2024-07-18	Warnings, Adverse reactions	Name fallback brand name: PEMETREXED generic name: PEMETREXED
Pemetrexed	PEMETREXED DISODIUM	Meitheal Pharmaceuticals Inc.	1ceacc3e-f555-489b-8b16-2baa58b2f5a5	2024-04-19	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED DISODIUM	Meitheal Pharmaceuticals Inc.	5fb3a2d5-b9ec-4044-abb9-3e0d848a448e	2024-04-19	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED DISODIUM	Waverley Pharma Inc	95633c32-89a8-4275-94e7-939c9f2e6135	2023-12-30	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED DISODIUM	BluePoint Laboratories	4cc1574b-3d2f-489b-9ad3-55695bb97200	2023-10-10	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed
Pemetrexed	PEMETREXED	BluePoint Laboratories	495c6751-8d6f-4093-8108-9bed283fce03	2023-09-05	Warnings, Adverse reactions	Name fallback brand name: Pemetrexed generic name: PEMETREXED

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-1060	Pemetrexed	Pemetrexed	Hospira, Inc.	NDA	Current
0409-1060	Pemetrexed	Pemetrexed	Hospira, Inc.	NDA	Current
0409-1060	Pemetrexed	Pemetrexed	Hospira, Inc.	NDA	Current
0409-1060	Pemetrexed	Pemetrexed	Hospira, Inc.	NDA	Current
0409-1061	Pemetrexed	Pemetrexed	Hospira, Inc.	NDA	Current
0409-1061	Pemetrexed	Pemetrexed	Hospira, Inc.	NDA	Current
0409-1061	Pemetrexed	Pemetrexed	Hospira, Inc.	NDA	Current
0409-1061	Pemetrexed	Pemetrexed	Hospira, Inc.	NDA	Current
0409-1062	Pemetrexed	Pemetrexed	Hospira, Inc.	NDA	Current
0409-1062	Pemetrexed	Pemetrexed	Hospira, Inc.	NDA	Current
0409-1062	Pemetrexed	Pemetrexed	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73084	ORIG	2023-01-04
71286	ORIG	2022-06-13
71271	ORIG	2022-06-13
65892	ORIG	2021-01-12