Application 210179

Type: ANDA
Sponsor: NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARMUSTINE	CARMUSTINE	INJECTABLE;INJECTION	100MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A210179-001	CARMUSTINE	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP		2018-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210179-001	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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210179-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2018-09-11	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A210179-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210179-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210179-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210179-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210179-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210179-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210179-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210179-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210179-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210179-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210179-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210179-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210179-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210179-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210179-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210179-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210179-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210179-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210179-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210179-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210179-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210179-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210179-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210179-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210179-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210179-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210179-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210179-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210179-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210179-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210179-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210179-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210179-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210179-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210179-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210179-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210179-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210179-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210179-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210179-001	AP	1	`3a93d1ddd44b…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARMUSTINE	CARMUSTINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b9b47082-32ee-4abb-a7b2-52292894d3f8	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARMUSTINE generic name: CARMUSTINE
Carmustine	CARMUSTINE	KVK-Tech, Inc.	11c3fad8-65ef-39a7-e063-6294a90a73e1	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carmustine generic name: CARMUSTINE
carmustine	CARMUSTINE	Dr. Reddy's Laboratories Inc.	7653a069-9cde-9ebf-5ccf-670f1a3f82b3	2025-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: carmustine generic name: CARMUSTINE
Carmustine	CARMUSTINE	Meitheal Pharmaceuticals Inc.	37a16d53-6a0d-4d24-a5f9-e8824b244b48	2025-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carmustine generic name: CARMUSTINE
CARMUSTINE	CARMUSTINE	Sandoz Inc.	82613f4f-05d1-4410-b288-15b6ad0fd069	2025-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARMUSTINE generic name: CARMUSTINE
CARMUSTINE	CARMUSTINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	e15140cd-aae9-43d6-aa6a-4e819238be36	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARMUSTINE generic name: CARMUSTINE
Gliadel	CARMUSTINE	Azurity Pharmaceuticals, Inc.	38962a55-a514-4c48-bea5-f99a8da4beec	2024-12-05	Warnings, Adverse reactions	Name fallback generic name: CARMUSTINE
carmustine	CARMUSTINE	Dr. Reddy's Laboratories Inc.	b946c396-34fc-1845-1944-f16028a8447d	2024-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: carmustine generic name: CARMUSTINE
Carmustine	CARMUSTINE	Novadoz Pharmaceuticals LLC	e6e28c8c-f793-41f3-aaeb-7bf412660288	2023-11-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carmustine generic name: CARMUSTINE
Carmustine	CARMUSTINE	Alembic Pharmaceuticals Limited	6e0cfe79-6998-45b2-bceb-f8848624be5a	2023-11-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carmustine generic name: CARMUSTINE
Carmustine	CARMUSTINE	Alembic Pharmaceuticals Inc.	cd2bd05c-c56a-46d2-b698-e085e289de95	2023-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carmustine generic name: CARMUSTINE
carmustine	CARMUSTINE	Amneal Pharmaceuticals LLC	2df937ad-a458-4030-bb7b-4468baa3685e	2023-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: carmustine generic name: CARMUSTINE

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68475-503	Carmustine	carmustine	Navinta LLC	ANDA	Current
68475-503	Carmustine	carmustine	Navinta LLC	ANDA	Current
68475-503	Carmustine	carmustine	Navinta LLC	ANDA	Current
68475-503	Carmustine	carmustine	Navinta LLC	ANDA	Current
68475-503	Carmustine	carmustine	Navinta LLC	ANDA	Current
70710-1525	carmustine	carmustine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1525	carmustine	carmustine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1525	carmustine	carmustine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1525	carmustine	carmustine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1525	carmustine	carmustine	Zydus Pharmaceuticals USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55950	ORIG	2018-10-15