Application 040555

Type: ANDA
Sponsor: LANNETT

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
A040555-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL			2005-04-15

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	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040555-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040555-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040555-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040555-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040555-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040555-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040555-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040555-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040555-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040555-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040555-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040555-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040555-001	AA	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040555-001	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 6 · 110 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	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	Aurolife Pharma LLC	5927e0f6-3de3-4885-a633-5b92003f6fe4	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: PHENTERMINE HYDROCHLORIDE generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	19f1ce79-65f4-4bf4-a9ff-6ca0a131530f	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	130e6087-0ab6-4456-a781-d370f363dc38	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
LOMAIRA	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	0718f0f3-77f2-45d7-be12-1ed718c8b806	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	d24aaa53-9c78-4c1b-9495-c785a9cf2b26	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	2f3b738f-d66b-40c1-8e69-bcd50bce3e47	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	27e88ebe-6247-4598-8ef2-c882992ed579	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	3d1d4dde-1c7f-4a20-b8f8-897b1b284f80	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Phentermine hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	d95e14f7-a46d-47fa-8dab-ee3d8d4c7b6d	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e6939fcf-3db2-492a-99ed-a384cdeea7a2	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	eae1d7f9-733c-434b-9199-5f7052e541da	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	328d6a39-34f4-4b74-a1bf-6ec6005b1322	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b425840f-380e-42bd-852a-6ee3641977ce	2026-03-23	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e48feec6-50c9-4ccd-b9da-56956d14c853	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	9155edf8-ea1d-458f-b2a7-e0303fd83cc0	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: Phentermine hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	c53bd3c5-01f6-4a21-9e3c-aa4969a01b4b	2026-03-04	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	aa9d7161-cda3-4ded-8d5b-424abd1a6681	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	fa5de92d-a5bf-4ae1-8e13-ad827aeebea3	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	86ec6b9d-2934-4bad-8a80-0b60e2f912f3	2026-01-24	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1445	Phentermine Hydrochloride	Phentermine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1445	Phentermine Hydrochloride	Phentermine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1445	Phentermine Hydrochloride	Phentermine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1445	Phentermine Hydrochloride	Phentermine Hydrochloride	Lannett Company, Inc.	ANDA	Current
17224-703	Phentermine Hydrochloride	Phentermine Hydrochloride	CALVIN, SCOTT AND COMPANY, INCORPORATED	ANDA	Current
17224-703	Phentermine Hydrochloride	Phentermine Hydrochloride	CALVIN, SCOTT AND COMPANY, INCORPORATED	ANDA	Current
43063-465	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50436-6744	Phentermine Hydrochloride	Phentermine Hydrochloride	Unit Dose Services	ANDA	Current
50436-6744	Phentermine Hydrochloride	Phentermine Hydrochloride	Unit Dose Services	ANDA	Current
51655-877	Phentermine hydrochloride	Phentermine hydrochloride	Northwind Pharmaceuticals	ANDA	Current
53002-7930	Phentermine Hydrochloride	Phentermine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-7930	Phentermine Hydrochloride	Phentermine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53217-171	Phentermine Hydrochloride	Phentermine Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
61919-186	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-186	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-186	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
63187-515	Phentermine Hydrochloride	Phentermine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-515	Phentermine Hydrochloride	Phentermine Hydrochloride	Proficient Rx LP	ANDA	Current
68788-9271	Phentermine Hydrochloride	Phentermine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9271	Phentermine Hydrochloride	Phentermine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9271	Phentermine Hydrochloride	Phentermine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9271	Phentermine Hydrochloride	Phentermine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
76420-057	Phentermine Hydrochloride	Phentermine Hydrochloride	Asclemed USA, Inc.	ANDA	Current
76420-057	Phentermine Hydrochloride	Phentermine Hydrochloride	Asclemed USA, Inc.	ANDA	Current
80425-0118	Adipex-P	Phentermine HCl 37.5mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0118	Phentermine HCL	Phentermine HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0118	Phentermine HCL	Phentermine HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current