Application 040875

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	CAPSULE;ORAL	30MG	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
A040875-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA		2008-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040875-001	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	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`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	A040875-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040875-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040875-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040875-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040875-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040875-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040875-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040875-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040875-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040875-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040875-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040875-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040875-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040875-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040875-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040875-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040875-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040875-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040875-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040875-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040875-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040875-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040875-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040875-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040875-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040875-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040875-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040875-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040875-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040875-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040875-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040875-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040875-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040875-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040875-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040875-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040875-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040875-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040875-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040875-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	6749c074-52a1-4d74-96a2-d9302b3c49a1	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040875 application number: ANDA040875 ndc (product): 55289-624
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	5234cabd-6b3e-404d-a0cd-256ee5fcc8f1	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040875 application number: ANDA040875 ndc (product): 50090-0416
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	7198d596-3e1c-49d5-91aa-c62fa2e2b800	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040875 application number: ANDA040875 ndc (product): 50090-5493
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	7f1c3a5d-dd9b-4441-a483-aa5777f8e40c	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040875 application number: ANDA040875 ndc (product): 71335-0564
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	KVK-Tech, Inc.	b963f7bb-fa65-4e28-81c9-282fbe70a6a6	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040875 application number: ANDA040875 ndc (product): 10702-028
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	f938b0ab-606e-8b21-e053-6294a90a4f4c	2023-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040875 application number: ANDA040875
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Proficient Rx LP	f2da0b5a-c7d6-48c3-98e9-7c611eb6ff7e	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040875 application number: ANDA040875 ndc (product): 63187-987

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-620	Phentermine Hydrochloride	Phentermine Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10702-028	Phentermine Hydrochloride	Phentermine Hydrochloride	KVK-Tech, Inc.	ANDA	Current
12634-516	Phentermine Hydrochloride	Phentermine Hydrochloride	Apotheca Inc.	ANDA	Current
33261-366	Phentermine Hydrochloride	Phentermine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
50090-0416	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5493	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50436-6746	Phentermine Hydrochloride	Phentermine Hydrochloride	Unit Dose Services	ANDA	Current
50436-6746	Phentermine Hydrochloride	Phentermine Hydrochloride	Unit Dose Services	ANDA	Current
55289-624	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-624	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-624	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-624	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-624	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-624	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
63187-987	Phentermine Hydrochloride	Phentermine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-987	Phentermine Hydrochloride	Phentermine Hydrochloride	Proficient Rx LP	ANDA	Current
66267-167	Phentermine Hydrochloride	Phentermine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-167	Phentermine Hydrochloride	Phentermine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66336-185	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	Dispensing Solutions, Inc.	ANDA	Current
71335-0564	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0564	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current