Home Applications 209851 Application 209851
Type ANDA
Sponsor APOTEX INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 750MG 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209851-001 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209851-001 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.
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 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 a50c72e98297…
Observed Orange Book normalized TE history# 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 BluePoint Laboratories 14974d4e-2f01-4e02-aea2-c28b3ca0781c 2023-04-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209851 application number: ANDA209851
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 60505-6068 Pemetrexed Pemetrexed disodium Apotex Corp ANDA Current 60505-6068 Pemetrexed Pemetrexed disodium Apotex Corp ANDA Current