Application 022468

Type: NDA
Sponsor: ACROTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOLOTYN	PRALATREXATE	SOLUTION;INTRAVENOUS	20MG/ML (20MG/ML)	Yes	No
002	FOLOTYN	PRALATREXATE	SOLUTION;INTRAVENOUS	40MG/2ML (20MG/ML)	Yes	Yes

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

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
N022468-001	FOLOTYN	PRALATREXATE	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2009-09-24
N022468-002	FOLOTYN	PRALATREXATE	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022468-001	AP
N022468-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2009-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2009-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2009-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2009-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022468-001	FOLOTYN	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD	2009-09-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022468-002	FOLOTYN	40MG/2ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-09-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022468-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022468-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022468-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022468-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022468-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022468-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022468-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022468-002	AP	1	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022468-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022468-002	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 192 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022468-001	7622470	2025-05-31	U-1015		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022468-001	8299078	2025-05-31	U-1004	2012-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022468-002	7622470	2025-05-31	U-1015		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022468-002	8299078	2025-05-31	U-1004		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022468-001	7622470	2025-05-31	U-1015		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022468-001	8299078	2025-05-31	U-1004	2012-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022468-002	7622470	2025-05-31	U-1015		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022468-002	8299078	2025-05-31	U-1004		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022468-001	7622470	2025-05-31	U-1015		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022468-001	8299078	2025-05-31	U-1004	2012-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022468-002	7622470	2025-05-31	U-1015		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022468-002	8299078	2025-05-31	U-1004		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022468-001	7622470	2025-05-31	U-1015		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022468-001	8299078	2025-05-31	U-1004	2012-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022468-002	7622470	2025-05-31	U-1015		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022468-002	8299078	2025-05-31	U-1004		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022468-001	7622470	2025-05-31	U-1015		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022468-001	8299078	2025-05-31	U-1004	2012-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022468-002	7622470	2025-05-31	U-1015		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022468-002	8299078	2025-05-31	U-1004		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022468-001	7622470	2025-05-31	U-1015		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022468-001	8299078	2025-05-31	U-1004	2012-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022468-002	7622470	2025-05-31	U-1015		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022468-002	8299078	2025-05-31	U-1004		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022468-001	7622470	2025-05-31	U-1015		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022468-001	8299078	2025-05-31	U-1004	2012-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022468-002	7622470	2025-05-31	U-1015		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022468-002	8299078	2025-05-31	U-1004		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022468-001	7622470	2025-05-31	U-1015		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022468-001	8299078	2025-05-31	U-1004	2012-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022468-002	7622470	2025-05-31	U-1015		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022468-002	8299078	2025-05-31	U-1004		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022468-001	7622470	2025-05-31	U-1015		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022468-001	8299078	2025-05-31	U-1004	2012-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022468-002	7622470	2025-05-31	U-1015		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022468-002	8299078	2025-05-31	U-1004		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022468-001	7622470	2025-05-31	U-1015		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022468-001	8299078	2025-05-31	U-1004	2012-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022468-002	7622470	2025-05-31	U-1015		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022468-002	8299078	2025-05-31	U-1004		`79d66fd596c7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Folotyn	PRALATREXATE	Acrotech Biopharma Inc	9f3d9c4d-9386-4451-b712-0fbdc5478d8f	2024-09-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022468 application number: NDA022468 ndc (product): 72893-005 ndc (product): 72893-003
Pralatrexate	PRALATREXATE	Fresenius Kabi USA, LLC	a5daa583-4965-4564-ad87-41ffe6c08a11	2022-11-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022468 application number: NDA022468 ndc (product): 65219-552 ndc (product): 65219-550

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
48818-001	Folotyn	pralatrexate	Allos Therapeutics	NDA	Current
48818-001	Folotyn	pralatrexate	Allos Therapeutics	NDA	Current
48818-001	Folotyn	pralatrexate	Acrotech Biopharma LLC	NDA	Current
65219-550	Pralatrexate	Pralatrexate	Fresenius Kabi USA, LLC	NDA AUTHORIZED GENERIC	Current
65219-552	Pralatrexate	Pralatrexate	Fresenius Kabi USA, LLC	NDA AUTHORIZED GENERIC	Current
72893-003	Folotyn	pralatrexate	Acrotech Biopharma LLC	NDA	Current
72893-003	Folotyn	pralatrexate	Acrotech Biopharma Inc	NDA	Current
72893-003	Folotyn	pralatrexate	Acrotech Biopharma LLC	NDA	Current
72893-003	Folotyn	pralatrexate	Acrotech Biopharma Inc	NDA	Current
72893-003	Folotyn	pralatrexate	Acrotech Biopharma LLC	NDA	Current
72893-003	Folotyn	pralatrexate	Acrotech Biopharma Inc	NDA	Current
72893-005	Folotyn	pralatrexate	Acrotech Biopharma LLC	NDA	Current
72893-005	Folotyn	pralatrexate	Acrotech Biopharma Inc	NDA	Current
72893-005	Folotyn	pralatrexate	Acrotech Biopharma LLC	NDA	Current
72893-005	Folotyn	pralatrexate	Acrotech Biopharma Inc	NDA	Current
72893-005	Folotyn	pralatrexate	Acrotech Biopharma LLC	NDA	Current
72893-005	Folotyn	pralatrexate	Acrotech Biopharma Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65005	SUPPL	2020-10-23
64960	SUPPL	2020-10-21
63137	SUPPL	2020-05-19
63041	SUPPL	2020-05-15
17621	SUPPL	2016-05-17
29762	SUPPL	2016-05-16
38746	SUPPL	2012-06-06
17620	SUPPL	2012-06-06
29761	SUPPL	2012-06-04
7437	SUPPL	2012-06-04
38745	SUPPL	2012-02-17
29760	SUPPL	2012-02-17
29759	SUPPL	2011-01-14
7436	SUPPL	2011-01-14
7435	SUPPL	2011-01-14
38744	SUPPL	2011-01-10
17619	SUPPL	2011-01-10
17618	SUPPL	2011-01-10
7434	SUPPL	2010-04-29
38743	SUPPL	2010-04-28
22029	ORIG	2009-11-23
29758	ORIG	2009-09-29
17617	ORIG	2009-09-25