Application 040886

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
002	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	CAPSULE;ORAL	15MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040886-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA		2008-03-31
A040886-002	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA		2008-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040886-001	AA
A040886-002	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 3 · 82 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	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A040886-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040886-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040886-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040886-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040886-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040886-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040886-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040886-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040886-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040886-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040886-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040886-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040886-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040886-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040886-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040886-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040886-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040886-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040886-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040886-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040886-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040886-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040886-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040886-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040886-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040886-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040886-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040886-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040886-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040886-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040886-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040886-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040886-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040886-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040886-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040886-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040886-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040886-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040886-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040886-002	AA	1	`782e0a99824c…`

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.	2f3b738f-d66b-40c1-8e69-bcd50bce3e47	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4000c00f-aa6c-4ea5-af0e-149dde3c74db	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886 ndc (product): 55289-791
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f115ad6d-cf62-40e7-89d1-6183a9b5071f	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886 ndc (product): 43063-961
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2abc445c-daa8-7326-e054-00144ff88e88	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886 ndc (product): 43063-654
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	5234cabd-6b3e-404d-a0cd-256ee5fcc8f1	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	1fe86035-19ef-4944-ad81-c0167a8e7fec	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0b4d847a-fcda-df31-e063-6294a90a0c5e	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	7f1c3a5d-dd9b-4441-a483-aa5777f8e40c	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886 ndc (product): 71335-0678
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	KVK-Tech, Inc.	b963f7bb-fa65-4e28-81c9-282fbe70a6a6	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886 ndc (product): 10702-027 ndc (product): 10702-026
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Proficient Rx LP	3a3259ec-ded3-427f-843d-928d130de3da	2020-03-01	Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886 ndc (product): 63187-512

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-099	Phentermine Hydrochloride	Phentermine Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10702-026	Phentermine Hydrochloride	Phentermine Hydrochloride	KVK-Tech, Inc.	ANDA	Current
10702-027	Phentermine Hydrochloride	Phentermine Hydrochloride	KVK-Tech, Inc.	ANDA	Current
12634-552	Phentermine Hydrochloride	Phentermine Hydrochloride	Apotheca Inc.	ANDA	Current
17224-650	Phentermine Hydrochloride	Phentermine Hydrochloride	CALVIN, SCOTT AND COMPANY, INCORPORATED	ANDA	Current
17224-650	Phentermine Hydrochloride	Phentermine Hydrochloride	CALVIN, SCOTT AND COMPANY, INCORPORATED	ANDA	Current
21695-509	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	Rebel Distributors Corp	ANDA	Current
33261-361	Phentermine Hydrochloride	Phentermine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
43063-654	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-654	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-654	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-654	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-961	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-961	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-961	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-961	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-961	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50436-3175	Phentermine Hydrochloride	Phentermine Hydrochloride	Unit Dose Services	ANDA	Current
50436-3175	Phentermine Hydrochloride	Phentermine Hydrochloride	Unit Dose Services	ANDA	Current
50436-3175	Phentermine Hydrochloride	Phentermine Hydrochloride	Unit Dose Services	ANDA	Current
50436-9029	Phentermine Hydrochloride	Phentermine Hydrochloride	Unit Dose Services	ANDA	Current
51655-872	Phentermine HCl	Phentermine HCl	Northwind Pharmaceuticals	ANDA	Current
55289-791	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-791	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-791	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-791	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-791	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-791	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
61919-316	PHENTERMINE HCL	PHENTERMINE HCL	DIRECT RX	ANDA	Current
61919-316	PHENTERMINE HCL	PHENTERMINE HCL	DIRECT RX	ANDA	Current
61919-316	PHENTERMINE HCL	PHENTERMINE HCL	DIRECT RX	ANDA	Current
63187-512	Phentermine Hydrochloride	Phentermine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-512	Phentermine Hydrochloride	Phentermine Hydrochloride	Proficient Rx LP	ANDA	Current
63629-4501	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0678	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0678	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current