Application 205046

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	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
A205046-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP		2017-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205046-001	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 2 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
2022-10-28 04:53 UTC	2022-10	A205046-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2017-04-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205046-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2017-04-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205046-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2017-04-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205046-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2017-04-26	`a50c72e98297…`

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	A205046-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205046-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205046-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205046-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205046-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205046-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205046-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205046-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205046-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205046-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205046-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205046-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205046-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205046-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205046-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205046-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205046-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205046-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205046-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205046-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205046-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205046-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205046-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205046-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205046-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205046-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205046-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205046-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205046-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205046-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205046-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205046-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205046-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205046-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205046-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205046-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205046-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205046-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205046-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205046-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmedetomidine HCl	DEXMEDETOMIDINE HCL	Medical Purchasing Solutions, LLC	ada70a68-3e52-4b94-e053-2995a90aa1e0	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205046 application number: ANDA205046 ndc (product): 71872-7218

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9532	Dexmedetomidine HCl	Dexmedetomidine HCl	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9532	Dexmedetomidine HCl	Dexmedetomidine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9532	Dexmedetomidine HCl	Dexmedetomidine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9532	Dexmedetomidine HCl	Dexmedetomidine HCl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
71872-7218	Dexmedetomidine HCl	Dexmedetomidine HCl	Medical Purchasing Solutions, LLC	ANDA	Current