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 1 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	Preferred Pharmaceuticals, Inc.	70bc6f36-8087-4ccd-a396-a911c0ebae79	2026-08-17	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	129e781c-5366-4986-8e67-6b35fa4c3f39	2026-08-17	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	d77f31b4-7e36-4a0a-a55b-78b4b6ab5cb7	2026-08-17	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Northwind Health Company, LLC	5528d9f7-45ad-d323-e063-6394a90a3e09	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	Aurolife Pharma LLC	5927e0f6-3de3-4885-a633-5b92003f6fe4	2026-06-10	Warnings, Adverse reactions	Name fallback 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 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 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 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 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 generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	d95e14f7-a46d-47fa-8dab-ee3d8d4c7b6d	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e6939fcf-3db2-492a-99ed-a384cdeea7a2	2026-05-11	Warnings, Adverse reactions	Name fallback 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 generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	328d6a39-34f4-4b74-a1bf-6ec6005b1322	2026-04-01	Warnings, Adverse reactions	Name fallback 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 generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e48feec6-50c9-4ccd-b9da-56956d14c853	2026-03-18	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	9155edf8-ea1d-458f-b2a7-e0303fd83cc0	2026-03-16	Warnings, Adverse reactions	Name fallback 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 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