Application 040747

Type: ANDA
Sponsor: TEDOR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
002	BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	TABLET;ORAL	25MG	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
A040747-001	BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL			2007-03-30
A040747-002	BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL			2015-11-20

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`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 · 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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
12634-118	Benzphetamine Hydrochloride	Benzphetamine Hydrochloride	Apotheca Inc.	ANDA	Current
53217-175	Benzphetamine Hydrochloride	Benzphetamine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
71335-0768	Benzphetamine Hydrochloride	Benzphetamine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
75834-100	Benzphetamine Hydrochloride	Benzphetamine Hydrochloride	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-102	Benzphetamine Hydrochloride	Benzphetamine Hydrochloride	Nivagen Pharmaceuticals, Inc.	ANDA	Current