Application 200177

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	TABLET;ORAL	25MG	No	Yes

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
A200177-001	DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200177-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA		2011-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200177-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-07-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A200177-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200177-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200177-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200177-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200177-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200177-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200177-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200177-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200177-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200177-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200177-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200177-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200177-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200177-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200177-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200177-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200177-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200177-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200177-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200177-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200177-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200177-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200177-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200177-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200177-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200177-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200177-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200177-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200177-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200177-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200177-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200177-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200177-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200177-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200177-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200177-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200177-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200177-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200177-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200177-001	AA	1	`e64feba35796…`

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
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5777eed8-c63d-49c4-9dd1-9d087906c368	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200177 application number: ANDA200177 ndc (product): 72789-117
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	A-S Medication Solutions	7f4eca5b-f850-44fc-88b4-4d9bcdf2ba44	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200177 application number: ANDA200177 ndc (product): 50090-2580
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	Chartwell RX, LLC.	b8984c2d-244e-4c56-be3e-c402dc679b1f	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200177 application number: ANDA200177
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	Bryant Ranch Prepack	54655904-7ce2-49d5-9acf-81ad9680d215	2024-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200177 application number: ANDA200177 ndc (product): 71335-0175
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	Proficient Rx LP	2a2fbc1b-6430-485b-b581-10fbfca0af88	2020-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200177 application number: ANDA200177 ndc (product): 63187-947
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	Lannett Company, Inc.	4fdbc049-6497-4ea0-8788-d2b2963328f7	2019-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200177 application number: ANDA200177 ndc (product): 0527-1475

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1475	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1475	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1475	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1475	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	Lannett Company, Inc.	ANDA	Current
50090-2580	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	A-S Medication Solutions	ANDA	Current
52959-150	DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	H.J. Harkins Company, Inc.	ANDA	Current
53217-230	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
63187-947	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	Proficient Rx LP	ANDA	Current
63187-947	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	Proficient Rx LP	ANDA	Current
63187-947	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	Proficient Rx LP	ANDA	Current
63629-8215	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8215	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68071-2171	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
71335-0175	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0175	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72789-117	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-117	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-117	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-117	Diethylpropion Hydrochloride	Diethylpropion Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current