Application 201050

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	CAPSULE;ORAL	10MG	No	No

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

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
A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL			2012-07-16

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 · 42 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	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2012-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201050-001	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	2012-07-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201050-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201050-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201050-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201050-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201050-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201050-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201050-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201050-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201050-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201050-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201050-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201050-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201050-001	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A201050-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201050-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201050-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201050-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201050-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201050-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201050-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201050-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201050-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201050-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201050-001	AB	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	NorthStar Rx LLC	48a047c0-f409-420b-990a-2cab953a96cd	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: PHENOXYBENZAMINE HYDROCHLORIDE generic name: PHENOXYBENZAMINE HYDROCHLORIDE
Phenoxybenzamine hydrochloride	PHENOXYBENZAMINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	0be6a394-cd10-42fc-97cf-ad53d81d8d93	2026-07-03	Warnings, Adverse reactions	Name fallback brand name: Phenoxybenzamine hydrochloride generic name: PHENOXYBENZAMINE HYDROCHLORIDE
phenoxybenzamine hydrochloride	PHENOXYBENZAMINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	1d2108fa-4352-4f3f-9314-732ed8b6394c	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: phenoxybenzamine hydrochloride generic name: PHENOXYBENZAMINE HYDROCHLORIDE
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	Burel Pharmaceuticals, LLC	609aa41e-4cb5-4cdf-9137-f429c21b4fab	2024-08-09	Warnings, Adverse reactions	Name fallback brand name: PHENOXYBENZAMINE HYDROCHLORIDE generic name: PHENOXYBENZAMINE HYDROCHLORIDE
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	Aurobindo Pharma Limited	75f26681-a079-4ff3-9fff-75526041374c	2024-02-16	Warnings, Adverse reactions	Name fallback brand name: PHENOXYBENZAMINE HYDROCHLORIDE generic name: PHENOXYBENZAMINE HYDROCHLORIDE
Phenoxybenzamine Hydrochloride	PHENOXYBENZAMINE HYDROCHLORIDE	Novitium Pharma LLC	2cb5fcd7-c37f-41de-8beb-0c7eded9ed04	2022-10-18	Warnings, Adverse reactions	Name fallback brand name: Phenoxybenzamine Hydrochloride generic name: PHENOXYBENZAMINE HYDROCHLORIDE

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
0054-0349	Phenoxybenzamine Hydrochloride	Phenoxybenzamine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0349	Phenoxybenzamine Hydrochloride	Phenoxybenzamine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52738	ORIG	2018-02-27
9857	ORIG	2012-07-18