Application 040876

Type: ANDA
Sponsor: KVK TECH

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
A040876-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		2008-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040876-001	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	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`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	A040876-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040876-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040876-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040876-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040876-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040876-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040876-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040876-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040876-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040876-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040876-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040876-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040876-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040876-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040876-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040876-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040876-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040876-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040876-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040876-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040876-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040876-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040876-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040876-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040876-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040876-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040876-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040876-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040876-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040876-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040876-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040876-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040876-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040876-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040876-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040876-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040876-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040876-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040876-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040876-001	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Northwind Health Company, LLC	5528d9f7-45ad-d323-e063-6394a90a3e09	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	86ec6b9d-2934-4bad-8a80-0b60e2f912f3	2026-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876 ndc (product): 50090-1679
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	68fcc228-5f06-4ece-94f3-59b5b33c3325	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876 ndc (product): 55289-701
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	c4e9ec2e-4660-4442-93d7-c05a16e137b5	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	315b8a94-b7cc-1b47-e063-6294a90a2d39	2025-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	2d7ddbc2-2afc-473e-a73b-b44ab9fcfaab	2025-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	DirectRx	d27d8379-aa3c-4688-e053-2995a90a44f6	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876 ndc (product): 72189-301
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	2bd5487d-10da-4ae0-9105-273e1a5efdcb	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876 ndc (product): 63629-4385
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	KVK-TECH, Inc.	3b44d104-a7d0-4366-9d42-63f784f3cb22	2024-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876 ndc (product): 10702-025

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-116	Phentermine Hydrochloride	Phentermine Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10702-025	Phentermine Hydrochloride	Phentermine Hydrochloride	KVK-TECH, Inc.	ANDA	Current
10702-025	Phentermine Hydrochloride	Phentermine Hydrochloride	KVK-TECH, Inc.	ANDA	Current
10702-025	Phentermine Hydrochloride	Phentermine Hydrochloride	KVK-TECH, Inc.	ANDA	Current
17224-702	Phentermine Hydrochloride	Phentermine Hydrochloride	CALVIN, SCOTT AND COMPANY, INCORPORATED	ANDA	Current
17224-702	Phentermine Hydrochloride	Phentermine Hydrochloride	CALVIN, SCOTT AND COMPANY, INCORPORATED	ANDA	Current
33261-471	Phentermine Hydrochloride	Phentermine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
49999-517	Phentermine Hydrochloride	Phentermine Hydrochloride	Lake Erie Medical DBA Quality Care Products	ANDA	Current
49999-517	Phentermine Hydrochloride	Phentermine Hydrochloride	Lake Erie Medical DBA Quality Care Products	ANDA	Current
50090-1679	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1679	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1679	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1679	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1679	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50436-0250	Phentermine Hydrochloride	Phentermine Hydrochloride	Unit Dose Services	ANDA	Current
50436-0250	Phentermine Hydrochloride	Phentermine Hydrochloride	Unit Dose Services	ANDA	Current
55289-701	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-701	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-701	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-701	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-701	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-701	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-701	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-701	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
63629-4385	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-4385	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68788-7823	Phentermine Hydrochloride	Phentermine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7823	Phentermine Hydrochloride	Phentermine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3407	Phentermine Hydrochloride	Phentermine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
72189-301	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	DirectRx	ANDA	Current
72189-301	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	DirectRx	ANDA	Current
75921-025	Phentermine Hydrochloride	Phentermine Hydrochloride	Life Line Home Care Services, Inc.	ANDA	Current