Application 090473

Type: ANDA
Sponsor: ANDA REPOSITORY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
002	BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A090473-001	BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL			2010-09-15
A090473-002	BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2010-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090473-002	AA

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090473-001	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL		2010-09-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090473-002	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-09-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090473-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090473-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090473-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090473-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090473-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090473-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090473-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090473-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090473-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090473-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090473-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090473-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090473-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090473-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090473-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090473-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090473-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090473-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090473-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090473-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090473-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090473-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090473-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090473-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090473-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090473-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090473-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090473-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090473-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090473-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090473-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090473-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090473-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090473-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090473-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090473-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090473-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090473-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090473-002	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090473-002	AA	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
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	KVK-TECH, INC	14d4589d-7f1c-4b6e-9557-59dad39b0960	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: BENZPHETAMINE HYDROCHLORIDE generic name: BENZPHETAMINE HYDROCHLORIDE
Benzphetamine Hydrochloride	BENZPHETAMINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	152a123e-4886-4184-a47d-462ce102b8fa	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: Benzphetamine Hydrochloride generic name: BENZPHETAMINE HYDROCHLORIDE
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2b7014af-0cc9-4199-90f2-ec07ac02f8cf	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: BENZPHETAMINE HYDROCHLORIDE generic name: BENZPHETAMINE HYDROCHLORIDE
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	Bryant Ranch Prepack	1c726aa7-3b78-45de-aca0-fd8a5fff9403	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: BENZPHETAMINE HYDROCHLORIDE generic name: BENZPHETAMINE HYDROCHLORIDE
Benzphetamine Hydrochloride	BENZPHETAMINE HYDROCHLORIDE	Epic Pharma, LLC	f6d9b369-4b64-4d3f-844d-5d60dd257c55	2023-12-27	Warnings, Adverse reactions	Name fallback brand name: Benzphetamine Hydrochloride generic name: BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride	BENZPHETAMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	f5c3c2ed-54a2-1def-e053-2995a90ab4e3	2023-03-02	Warnings, Adverse reactions	Name fallback brand name: benzphetamine hydrochloride generic name: BENZPHETAMINE HYDROCHLORIDE

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
43547-263	benzphetamine hydrochloride	benzphetamine hydrochloride	Solco Healthcare US LLC	ANDA	Current
46672-843	benzphetamine hydrochloride	benzphetamine hydrochloride	Mikart, LLC	ANDA	Current
46672-843	benzphetamine hydrochloride	benzphetamine hydrochloride	Mikart, LLC	ANDA	Current
46672-843	benzphetamine hydrochloride	benzphetamine hydrochloride	Mikart, LLC	ANDA	Current
46672-844	benzphetamine hydrochloride	benzphetamine hydrochloride	Mikart, LLC	ANDA	Current
46672-844	benzphetamine hydrochloride	benzphetamine hydrochloride	Mikart, LLC	ANDA	Current
46672-844	benzphetamine hydrochloride	benzphetamine hydrochloride	Mikart, LLC	ANDA	Current
66992-399	Regimex	benzphetamine hydrochloride	Wraser Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22709	ORIG	2012-06-22