Application 085128

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADIPEX-P	PHENTERMINE HYDROCHLORIDE	TABLET;ORAL	37.5MG	No	Yes

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
A085128-001	ADIPEX-P	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A085128-001	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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085128-001	ADIPEX-P	37.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A085128-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A085128-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085128-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085128-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085128-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085128-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085128-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085128-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085128-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085128-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085128-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085128-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085128-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085128-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085128-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085128-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085128-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085128-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085128-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085128-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085128-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085128-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085128-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085128-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085128-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085128-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085128-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085128-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085128-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085128-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085128-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085128-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085128-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085128-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085128-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085128-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085128-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085128-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085128-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085128-001	AA	1	`f41ea6bd6efb…`

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 4 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	NuCare Pharmaceuticals,Inc.	0b4d847a-fcda-df31-e063-6294a90a0c5e	2025-02-03	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e08b4f49-de9f-490d-b11d-d865439f5fad	2025-01-31	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	70f68311-8d1f-4b8e-b8a7-13bc4c17727e	2025-01-31	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	86a6ce50-673d-4031-87a0-51965cc1e795	2025-01-28	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e0a6a289-7dbf-4b24-b815-46dee0d19fdc	2025-01-24	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	99c1325b-7152-481d-8a1f-6bf3e2c4808b	2025-01-24	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	6b08ccd5-d01f-48f1-80a2-1d121f445d42	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	5d84078d-ff2d-4800-b2f4-f1d30c8335bb	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	DirectRx	ca683656-16a6-9602-e053-2a95a90aa895	2025-01-20	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	DirectRx	d27d8379-aa3c-4688-e053-2995a90a44f6	2025-01-20	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	DIRECT RX	c3dda0a4-b428-f3e7-e053-2995a90ad106	2025-01-17	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	SUNRISE PHARMACEUTICAL, INC.	43024f64-2d77-49a9-80fd-ad07a86c69a3	2024-12-03	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	50efa498-11c5-41fa-95ac-419fcc10da03	2024-11-01	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	c8516abe-5ad1-4b76-8e2c-96ee455979cf	2024-10-17	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HCL	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	8fe6b65d-ca61-40f0-90fc-255dfd075611	2024-10-15	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8abf898e-318b-3519-e053-2995a90abf2f	2024-09-11	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1fa8798d-c096-5839-e063-6394a90aa28b	2024-09-03	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	2bd5487d-10da-4ae0-9105-273e1a5efdcb	2024-08-20	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	f427f067-f1a7-4d60-8ce0-90b20e2d4eb5	2024-08-20	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	f50f5453-e06d-4e39-b868-9bdadf1d8baa	2024-08-20	Warnings, Adverse reactions	Name fallback 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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55289-379	Adipex-P	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-379	Adipex-P	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-379	Adipex-P	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-379	Adipex-P	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
57844-009	Adipex-P	Phentermine Hydrochloride	Teva Select Brands	ANDA	Current
57844-009	Adipex-P	Phentermine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
57844-009	Adipex-P	Phentermine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
57844-009	Adipex-P	Phentermine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
57844-009	Adipex-P	Phentermine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
57844-009	Adipex-P	Phentermine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
57844-009	Adipex-P	Phentermine Hydrochloride	Teva Select Brands	ANDA	Current
57844-009	Adipex-P	Phentermine Hydrochloride	Teva Select Brands	ANDA	Current
57844-140	Adipex-P	Phentermine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
57844-140	Adipex-P	Phentermine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
72789-175	Adipex-P	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-175	Adipex-P	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39587	SUPPL	2012-04-16