Application 040887

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	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
A040887-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA		2008-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040887-001	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	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`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	A040887-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040887-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040887-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040887-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040887-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040887-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040887-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040887-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040887-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040887-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040887-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040887-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040887-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040887-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040887-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040887-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040887-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040887-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040887-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040887-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040887-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040887-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040887-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040887-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040887-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040887-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040887-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040887-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040887-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040887-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040887-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040887-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040887-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040887-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040887-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040887-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040887-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040887-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040887-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040887-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	27e88ebe-6247-4598-8ef2-c882992ed579	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040887 application number: ANDA040887
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	ea798229-fc2d-417c-9bc9-a3b942f0b64b	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040887 application number: ANDA040887 ndc (product): 50090-0653
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	378d863a-6977-4543-ae50-c3684a6abd9b	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040887 application number: ANDA040887 ndc (product): 43063-182
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	KVK-TECH, Inc.	3b44d104-a7d0-4366-9d42-63f784f3cb22	2024-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040887 application number: ANDA040887 ndc (product): 10702-029

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-592	Phentermine Hydrochloride	Phentermine Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10702-029	Phentermine Hydrochloride	Phentermine Hydrochloride	KVK-TECH, Inc.	ANDA	Current
10702-029	Phentermine Hydrochloride	Phentermine Hydrochloride	KVK-TECH, Inc.	ANDA	Current
10702-029	Phentermine Hydrochloride	Phentermine Hydrochloride	KVK-TECH, Inc.	ANDA	Current
33261-408	Phentermine Hydrochloride	Phentermine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
43063-182	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-182	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-182	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-182	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-182	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-182	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-182	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-0653	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0653	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0653	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50436-6743	Phentermine Hydrochloride	Phentermine Hydrochloride	Unit Dose Services	ANDA	Current
63629-3211	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-3211	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current