Application 091359

Type: ANDA
Sponsor: LANNETT CO INC

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 43.

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
A091359-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			2010-07-16

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 · 43 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
2026-09-14 22:38:34	2026-08	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2010-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2010-07-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A091359-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091359-001	AA	1	`ea99ee380514…`

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 2 of 6 · 109 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.	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
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	ea798229-fc2d-417c-9bc9-a3b942f0b64b	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	0e893b62-bb07-4984-9f0a-3601435fbc27	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	1149f69d-65df-6a98-e063-6394a90aeaa4	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	4686bc8d-7173-477e-96c8-a7d33653df2e	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Phentermine hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	d76940d3-95e6-442d-99ef-4fe92de7a376	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Northwind Health Company, LLC	1b5396a8-e7ef-45ae-e063-6294a90a14a2	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	TAGI Pharma, Inc.	1993b181-f4f1-4451-92a0-7ed8f32598ba	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Precision Dose Inc.	8d5697b9-02e8-40c4-97c7-761d635243c8	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Precision Dose Inc.	095a2be5-721e-46e6-976f-9137c855cd22	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	a9270c14-499f-4c07-a1eb-c0aab5d8731f	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	6749c074-52a1-4d74-96a2-d9302b3c49a1	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	68fcc228-5f06-4ece-94f3-59b5b33c3325	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4000c00f-aa6c-4ea5-af0e-149dde3c74db	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f115ad6d-cf62-40e7-89d1-6183a9b5071f	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	378d863a-6977-4543-ae50-c3684a6abd9b	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	abf702d6-6f94-48dc-ad23-c52fd74e83a8	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2abc445c-daa8-7326-e054-00144ff88e88	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1438	Phentermine Hydrochloride	Phentermine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1438	Phentermine Hydrochloride	Phentermine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1438	Phentermine Hydrochloride	Phentermine Hydrochloride	Lannett Company, Inc.	ANDA	Current
61919-244	PHENTERMINE HCL	PHENTERMINE HCL	DIRECT RX	ANDA	Current
61919-865	PHENTERMINE HCL C-IV	PHENTERMINE HCL C-IV	Direct_Rx	ANDA	Current
61919-865	PHENTERMINE HCL C-IV	PHENTERMINE HCL C-IV	Direct_Rx	ANDA	Current
61919-865	PHENTERMINE HCL C-IV	PHENTERMINE HCL C-IV	Direct_Rx	ANDA	Current
63629-5075	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-5075	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-5075	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-5075	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7122	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7122	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71205-250	Phentermine Hydrochloride	Phentermine Hydrochloride	Proficient Rx LP	ANDA	Current
71205-250	Phentermine Hydrochloride	Phentermine Hydrochloride	Proficient Rx LP	ANDA	Current