Application 205008

Type: ANDA
Sponsor: NUVO PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	TABLET;ORAL	37.5MG	No	No

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

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
A205008-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		2014-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205008-001	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 · 41 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	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205008-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-09-25	`cb3db0bc1861…`

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	A205008-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205008-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205008-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205008-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205008-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205008-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205008-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205008-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205008-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205008-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205008-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205008-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205008-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205008-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205008-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205008-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205008-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205008-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205008-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205008-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205008-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205008-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205008-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205008-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205008-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205008-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205008-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205008-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205008-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205008-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205008-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205008-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205008-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205008-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205008-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205008-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205008-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205008-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205008-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205008-001	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	3d1d4dde-1c7f-4a20-b8f8-897b1b284f80	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008 ndc (product): 17224-904
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	9155edf8-ea1d-458f-b2a7-e0303fd83cc0	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	129e781c-5366-4986-8e67-6b35fa4c3f39	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008 ndc (product): 68788-7906
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e08b4f49-de9f-490d-b11d-d865439f5fad	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e0a6a289-7dbf-4b24-b815-46dee0d19fdc	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008 ndc (product): 63629-2389
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	99c1325b-7152-481d-8a1f-6bf3e2c4808b	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008 ndc (product): 63629-2388
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	SUNRISE PHARMACEUTICAL, INC.	43024f64-2d77-49a9-80fd-ad07a86c69a3	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008 ndc (product): 11534-160
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	50efa498-11c5-41fa-95ac-419fcc10da03	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1fa8798d-c096-5839-e063-6394a90aa28b	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Proficient Rx LP	28fda2ce-d445-47ce-8764-bf113b5db5b3	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008 ndc (product): 71205-668
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Asclemed USA, Inc.	de76ed27-ac43-4923-b73f-461d33941f6b	2020-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008 ndc (product): 76420-108

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11534-160	Phentermine hydrochloride	phentermine hydrochloride	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-160	Phentermine hydrochloride	phentermine hydrochloride	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
11534-160	Phentermine hydrochloride	phentermine hydrochloride	SUNRISE PHARMACEUTICAL, INC.	ANDA	Current
17224-904	Phentermine hydrochloride	phentermine hydrochloride	CALVIN, SCOTT AND COMPANY, INCORPORATED	ANDA	Current
53002-7931	Phentermine hydrochloride	phentermine hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-7931	Phentermine hydrochloride	phentermine hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
63629-2388	Phentermine hydrochloride	phentermine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2388	Phentermine hydrochloride	phentermine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2389	Phentermine hydrochloride	phentermine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2389	Phentermine hydrochloride	phentermine hydrochloride	Bryant Ranch Prepack	ANDA	Current
68788-7906	Phentermine hydrochloride	phentermine hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7906	Phentermine hydrochloride	phentermine hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
71205-668	Phentermine hydrochloride	phentermine hydrochloride	Proficient Rx LP	ANDA	Current
71205-668	Phentermine hydrochloride	phentermine hydrochloride	Proficient Rx LP	ANDA	Current
76420-108	Phentermine hydrochloride	phentermine hydrochloride	Asclemed USA, Inc.	ANDA	Current