Application 090591

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	CAPSULE;ORAL	15MG	No	No
002	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090591-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL			2010-03-18
A090591-002	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			2010-03-18

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 · 86 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	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2010-03-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090591-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2010-03-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090591-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2010-03-18	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090591-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090591-002	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090591-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090591-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090591-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090591-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090591-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090591-002	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 5 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	Bryant Ranch Prepack	53cad049-f1b4-42c0-9cc7-a1c2df75ac58	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	bd7393cb-2b72-4ecd-ba03-801b635b7647	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	3c37d637-779d-4097-85ef-e4ce7d0fb86a	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	0ca26b58-0a93-4a10-be4d-63a4ad5eecf8	2024-06-06	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	7f1c3a5d-dd9b-4441-a483-aa5777f8e40c	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	KVK-Tech, Inc.	b963f7bb-fa65-4e28-81c9-282fbe70a6a6	2024-04-18	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	ac8559a0-98fe-4737-b9ec-e36eef3b14fc	2024-04-08	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	c5d60a6d-2410-4a3c-88e1-a6126b56cf6a	2024-04-08	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	KVK-TECH, Inc.	3b44d104-a7d0-4366-9d42-63f784f3cb22	2024-02-14	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	95f908c2-1003-4e8f-8e4a-86f493456878	2024-01-15	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
LOMAIRA	PHENTERMINE HYDROCHLORIDE	KVK-TECH, INC.	cde9fb09-e5af-434d-8874-e4f9f974d893	2023-12-19	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	81751ece-8ccb-4aec-91ad-037c1d9fea53	2023-11-16	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	707af68e-1630-4f86-87ba-1a643d2b4ef9	2023-10-09	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	83802088-f4fc-4b34-9268-d63fb2ad1655	2023-09-27	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Asclemed USA, Inc.	22683183-a828-47a4-9e52-38175d7c6f21	2023-09-01	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Proficient Rx LP	b14a8f6a-a1c6-4104-80f2-0fa35320d04c	2023-05-01	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	f938b0ab-606e-8b21-e053-6294a90a4f4c	2023-04-13	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Proficient Rx LP	5e1cc734-5d5c-429e-8b4c-4401a01cfba2	2023-04-01	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	8c7c1391-bfd1-48f9-b249-9729fe648b89	2023-02-04	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Proficient Rx LP	28fda2ce-d445-47ce-8764-bf113b5db5b3	2022-11-01	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.