Application 090384

Type: ANDA
Sponsor: APP PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEMETREXED	PEMETREXED	INJECTABLE; INJECTION	500MG	No	No
002	PEMETREXED	PEMETREXED	INJECTABLE;INJECTION	100MG	No	No
003	PEMETREXED	PEMETREXED	INJECTABLE;INJECTION	1G	No	No
004	PEMETREXED DISODIUM	PEMETREXED DISODIUM	POWDER;INTRAVENOUS	EQ 1GM 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090384-001	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25
A090384-002	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25
A090384-003	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25
A090384-004	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090384-001	AP
A090384-002	AP
A090384-003	AP
A090384-004	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 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090384-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090384-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090384-003	PEMETREXED DISODIUM	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090384-004	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090384-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090384-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090384-003	PEMETREXED DISODIUM	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090384-004	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090384-001	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	A090384-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090384-003	PEMETREXED DISODIUM	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090384-004	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090384-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090384-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090384-003	PEMETREXED DISODIUM	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090384-004	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090384-001	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	A090384-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090384-003	PEMETREXED DISODIUM	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090384-004	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090384-001	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	A090384-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090384-003	PEMETREXED DISODIUM	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090384-004	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090384-001	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	A090384-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090384-003	PEMETREXED DISODIUM	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090384-004	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090384-001	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	A090384-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090384-003	PEMETREXED DISODIUM	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090384-004	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090384-001	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	A090384-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090384-003	PEMETREXED DISODIUM	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090384-004	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090384-001	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	A090384-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090384-003	PEMETREXED DISODIUM	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090384-004	PEMETREXED DISODIUM	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RS	2022-05-25	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 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	A090384-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090384-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090384-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090384-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090384-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090384-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090384-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090384-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090384-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090384-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090384-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090384-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090384-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090384-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090384-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090384-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090384-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090384-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090384-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090384-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090384-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090384-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090384-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090384-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090384-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090384-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090384-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090384-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090384-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090384-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090384-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090384-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090384-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090384-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090384-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090384-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090384-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090384-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090384-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090384-004	AP	1	`d8e5a09893c0…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pemetrexed	PEMETREXED DISODIUM	Fresenius Kabi USA, LLC	ae77f00f-d43b-4b75-afd5-a2a9cb7138da	2025-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090384 application number: ANDA090384 ndc (product): 63323-622 ndc (product): 63323-450 ndc (product): 63323-621 ndc (product): 63323-134

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-134	Pemetrexed	PEMETREXED DISODIUM	Fresenius Kabi USA, LLC	ANDA	Current
63323-450	Pemetrexed	PEMETREXED DISODIUM	Fresenius Kabi USA, LLC	ANDA	Current
63323-621	Pemetrexed	PEMETREXED DISODIUM	Fresenius Kabi USA, LLC	ANDA	Current
63323-622	Pemetrexed	PEMETREXED DISODIUM	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71899	ORIG	2022-08-26