Application 075371

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DACARBAZINE	DACARBAZINE	INJECTABLE;INJECTION	100MG/VIAL	No	Yes
002	DACARBAZINE	DACARBAZINE	INJECTABLE;INJECTION	200MG/VIAL	No	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
A075371-001	DACARBAZINE	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27
A075371-002	DACARBAZINE	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075371-002	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	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075371-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075371-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075371-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075371-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075371-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075371-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075371-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075371-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075371-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075371-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075371-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075371-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075371-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075371-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075371-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075371-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075371-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075371-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075371-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075371-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075371-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075371-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075371-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075371-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075371-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075371-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075371-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075371-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075371-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075371-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075371-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075371-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075371-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075371-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075371-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075371-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075371-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075371-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075371-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075371-002	AP	1	`cb3db0bc1861…`

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	Fresenius Kabi USA, LLC	b6b97e41-5f15-498c-abfb-d8443ea4d216	2022-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075371 application number: ANDA075371 ndc (product): 63323-127 ndc (product): 63323-128

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
63323-127	Dacarbazine	DACARBAZINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-127	Dacarbazine	DACARBAZINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-127	Dacarbazine	DACARBAZINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-128	Dacarbazine	DACARBAZINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-128	Dacarbazine	DACARBAZINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-128	Dacarbazine	DACARBAZINE	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8637	ORIG	1999-08-27