Application 084835

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	TABLET;ORAL	35MG	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
A084835-001	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL		Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084835-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	Approved before 1982	`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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	Preferred Pharmaceuticals Inc.	767b5386-1e56-4eeb-8d59-510b940ab75e	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	Calvin Scott & Co., Inc.	f5c30a88-5814-5b42-e053-2995a90a437a	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Bryant Ranch Prepack	75f6c4bc-ed72-498a-822c-ecc2a13df958	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: PHENDIMETRAZINE TARTRATE generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	A-S Medication Solutions	ef4cfd54-7d3e-4571-ae77-38ab2fd1af3d	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Acertis Pharmaceuticals, LLC	162140d3-b833-4633-9759-95821a46a690	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: PHENDIMETRAZINE TARTRATE generic name: PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Virtus Pharmaceuticals, LLC	cc9a0cd2-6fb9-47ab-8e39-146d2fa361c2	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: PHENDIMETRAZINE TARTRATE generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	NuCare Pharmaceuticals, Inc.	342bc2a2-2751-b51a-e063-6394a90a4c43	2025-05-02	Warnings, Adverse reactions	Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	A-S Medication Solutions	f1d265e1-522e-4a62-afda-29477fb94b8d	2025-04-04	Warnings, Adverse reactions	Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Bryant Ranch Prepack	137e5fcd-9536-4fb9-9885-5dfd1127c35a	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: PHENDIMETRAZINE TARTRATE generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	PD-Rx Pharmaceuticals, Inc.	467ae7d7-e342-423b-be89-5d38c1abf3c9	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	KVK-TECH, INC	07bf3488-09e7-436f-af3f-94c35a7be025	2024-12-06	Warnings, Adverse reactions	Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	NuCare Pharmaceuticals,Inc.	05bb0569-4eed-2139-e063-6394a90acb6c	2024-09-27	Warnings, Adverse reactions	Name fallback brand name: PHENDIMETRAZINE TARTRATE generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	NuCare Pharmaceuticals, Inc,	40e5b0bf-347e-30f6-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	Bryant Ranch Prepack	1c2370fd-6b40-48dc-a42d-2488041d5b37	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	A-S Medication Solutions	7adaf128-fef4-4bbf-8b4a-875fe46bf68a	2023-07-18	Warnings, Adverse reactions	Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Bryant Ranch Prepack	8593421c-d1fb-409d-a5bb-3369da18fd2c	2023-07-12	Warnings, Adverse reactions	Name fallback brand name: PHENDIMETRAZINE TARTRATE generic name: PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Elite Laboratories, Inc	42ecacde-6859-47c6-ba44-13fb4f3b5448	2019-02-07	Warnings, Adverse reactions	Name fallback brand name: PHENDIMETRAZINE TARTRATE generic name: PHENDIMETRAZINE TARTRATE

Reported adverse events (FAERS/openFDA)#

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