Application 079001

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VECURONIUM BROMIDE	VECURONIUM BROMIDE	INJECTABLE;INJECTION	10MG/VIAL	No	Yes
002	VECURONIUM BROMIDE	VECURONIUM BROMIDE	INJECTABLE;INJECTION	20MG/VIAL	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A079001-001	VECURONIUM BROMIDE	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP		2009-06-17
A079001-002	VECURONIUM BROMIDE	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION			2009-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079001-001	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP		2009-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION			2009-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079001-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079001-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-06-17	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A079001-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079001-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079001-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079001-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079001-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079001-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079001-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079001-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079001-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079001-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079001-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079001-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079001-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079001-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079001-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079001-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079001-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079001-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079001-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079001-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079001-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079001-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079001-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079001-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079001-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079001-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079001-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079001-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079001-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079001-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079001-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079001-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079001-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079001-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079001-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079001-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079001-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079001-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079001-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079001-001	AP	1	`782e0a99824c…`

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
vecuronium bromide	VECURONIUM BROMIDE	Sun Pharmaceutical Industries, Inc.	a14da3ee-a731-4282-be9d-407473517470	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079001 application number: ANDA079001 ndc (product): 47335-931 ndc (product): 47335-932

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
47335-931	vecuronium bromide	vecuronium bromide	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-932	vecuronium bromide	vecuronium bromide	Sun Pharmaceutical Industries, Inc.	ANDA	Current