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 3 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	A-S Medication Solutions	5234cabd-6b3e-404d-a0cd-256ee5fcc8f1	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	7198d596-3e1c-49d5-91aa-c62fa2e2b800	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	640d71d8-45c9-42fb-ad96-2f3ac60afc9c	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	fe78b5b4-47bf-484b-ab37-e0d7de6fad57	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e4508aa9-1e7a-4af7-829e-5fa353c92f5e	2025-08-22	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Chartwell RX, LLC	d70f0be3-fcc7-4a1d-9a82-bb1bb21a1528	2025-08-19	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	c4e9ec2e-4660-4442-93d7-c05a16e137b5	2025-07-23	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	12699287-9ca9-07b3-e063-6294a90af21a	2025-07-23	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	1fe86035-19ef-4944-ad81-c0167a8e7fec	2025-07-23	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd	2025-07-21	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	02b8f684-b1ca-4ab7-9567-bcacc6a92779	2025-07-14	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	SUNRISE PHARMACEUTICAL, INC.	a0439c85-5ede-4e02-aed2-47debd2c8eb2	2025-07-08	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	723c37c4-868f-40f0-b74d-137dcbb93f9f	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	a1bca4b5-df64-4bac-a3a2-67f5c1eddbce	2025-05-12	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	f3b43443-dcf3-4a0d-a919-1be1bb9495ed	2025-04-24	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	315b8a94-b7cc-1b47-e063-6294a90a2d39	2025-03-27	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	312d9742-6a65-c1cb-e063-6394a90a2e66	2025-03-25	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	30b48126-45f3-21fa-e063-6294a90a968f	2025-03-19	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Solco Healthcare U.S., LLC	e4024b8a-25cb-4681-9bb4-44a38c74fe4b	2025-03-06	Warnings, Adverse reactions	Name fallback brand name: Phentermine Hydrochloride generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	2d7ddbc2-2afc-473e-a73b-b44ab9fcfaab	2025-02-26	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.