Home Applications 075259 Application 075259
Type ANDA
Sponsor TEVA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DACARBAZINE DACARBAZINE INJECTABLE;INJECTION 500MG/VIAL No Yes 002 DACARBAZINE DACARBAZINE INJECTABLE;INJECTION 200MG/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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075259-001 DACARBAZINE DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 A075259-002 DACARBAZINE DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27
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 · 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 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075259-001 DACARBAZINE 500MG/VIAL INJECTABLE / INJECTION AP RS 2000-09-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075259-002 DACARBAZINE 200MG/VIAL INJECTABLE / INJECTION AP 1998-08-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 Dacarbazine DACARBAZINE Meitheal Pharmaceuticals Inc. 64037f45-6245-49f0-9ae8-18d75753ae1f 2024-03-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075259 application number: ANDA075259
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0703-5075 Dacarbazine Dacarbazine Teva Parenteral Medicines, Inc. ANDA Current 0703-5075 Dacarbazine Dacarbazine Teva Parenteral Medicines, Inc. ANDA Current 0703-5075 Dacarbazine Dacarbazine Teva Parenteral Medicines, Inc. ANDA Current 0703-5075 Dacarbazine Dacarbazine Teva Parenteral Medicines, Inc. ANDA Current 0703-5075 Dacarbazine Dacarbazine Teva Parenteral Medicines, Inc. ANDA Current 0703-5075 Dacarbazine Dacarbazine Teva Parenteral Medicines, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30822 ORIG 1998-08-27