Application 205390

Type: ANDA
Sponsor: GLAND PHARMA LTD

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	No
002	VECURONIUM BROMIDE	VECURONIUM BROMIDE	INJECTABLE;INJECTION	20MG/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205390-001	VECURONIUM BROMIDE	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP		2016-05-26
A205390-002	VECURONIUM BROMIDE	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP		2016-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A205390-001	AP
A205390-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205390-001	VECURONIUM BROMIDE	10MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205390-002	VECURONIUM BROMIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	2016-05-26	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A205390-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205390-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205390-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205390-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205390-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205390-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205390-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205390-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205390-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205390-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205390-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205390-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205390-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205390-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205390-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205390-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205390-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205390-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205390-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205390-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205390-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205390-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205390-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205390-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205390-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205390-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205390-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205390-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205390-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205390-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205390-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205390-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205390-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205390-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205390-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205390-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205390-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205390-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205390-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205390-002	AP	1	`bb7c543d1eb4…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vecuronium Bromide	VECURONIUM BROMIDE	Mullan Pharmaceutical Inc.	aa35d139-25c8-4802-b165-0db7d1c08913	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205390 application number: ANDA205390
Vecuronium Bromide	VECURONIUM BROMIDE	Sagent Pharmaceuticals	dff452e8-71e7-437e-bed0-3e1bd9441bc6	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205390 application number: ANDA205390
Vecuronium Bromide	VECURONIUM BROMIDE	Gland Pharma Limited	5ae91612-4f65-4e52-8901-c37010612eaf	2018-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205390 application number: ANDA205390 ndc (product): 68083-139 ndc (product): 68083-140

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-781	Vecuronium Bromide	Vecuronium Bromide	Fresenius Kabi USA, LLC	ANDA	Current
63323-781	Vecuronium Bromide	Vecuronium Bromide	Fresenius Kabi USA, LLC	ANDA	Current
63323-781	Vecuronium Bromide	Vecuronium Bromide	Fresenius Kabi USA, LLC	ANDA	Current
63323-781	Vecuronium Bromide	Vecuronium Bromide	Fresenius Kabi USA, LLC	ANDA	Current
63323-782	Vecuronium Bromide	Vecuronium Bromide	Fresenius Kabi USA, LLC	ANDA	Current
63323-782	Vecuronium Bromide	Vecuronium Bromide	Fresenius Kabi USA, LLC	ANDA	Current
68083-139	Vecuronium Bromide	Vecuronium Bromide	Gland Pharma Limited	ANDA	Current
68083-140	Vecuronium Bromide	Vecuronium Bromide	Gland Pharma Limited	ANDA	Current