Home Applications 022468 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 43 .
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.
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 · 86 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 2026-09-14 22:38:34 2026-08 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD 2009-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-09-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD 2009-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-09-24 caaa826d4ba7…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…
Observed Orange Book normalized TE history# 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 Coverage / status 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 · 1 matching rows.
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 · 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