Application 085588

Type: ANDA
Sponsor: VIRTUS PHARMS

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 1.

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
A085588-001	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	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
A085588-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085588-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085588-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085588-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085588-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085588-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085588-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085588-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085588-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085588-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085588-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085588-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085588-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085588-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085588-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085588-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085588-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085588-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085588-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085588-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085588-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085588-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085588-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085588-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085588-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085588-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085588-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085588-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085588-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085588-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085588-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085588-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085588-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085588-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085588-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085588-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085588-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085588-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085588-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085588-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085588-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085588-001	AA	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Bryant Ranch Prepack	75f6c4bc-ed72-498a-822c-ecc2a13df958	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085588 application number: ANDA085588 ndc (product): 63629-2489
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Virtus Pharmaceuticals, LLC	cc9a0cd2-6fb9-47ab-8e39-146d2fa361c2	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085588 application number: ANDA085588 ndc (product): 69543-410
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Bryant Ranch Prepack	137e5fcd-9536-4fb9-9885-5dfd1127c35a	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085588 application number: ANDA085588 ndc (product): 71335-1840

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-4057	Phendimetrazine Tartrate	Phendimetrazine Tartrate	Eon Labs, Inc.	ANDA	Current
17224-501	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	CALVIN, SCOTT AND COMPANY, INCORPORATED	ANDA	Current
17224-501	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	CALVIN, SCOTT AND COMPANY, INCORPORATED	ANDA	Current
21695-597	Phendimetrazine Tartrate	Phendimetrazine Tartrate	Rebel Distributors Corp	ANDA	Current
50090-2592	Phendimetrazine Tartrate	Phendimetrazine Tartrate	A-S Medication Solutions	ANDA	Current
50090-2592	Phendimetrazine Tartrate	Phendimetrazine Tartrate	A-S Medication Solutions	ANDA	Current
50090-5859	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	A-S Medication Solutions	ANDA	Current
63187-898	Phendimetrazine Tartrate	Phendimetrazine Tartrate	Proficient Rx LP	ANDA	Current
63187-898	Phendimetrazine Tartrate	Phendimetrazine Tartrate	Proficient Rx LP	ANDA	Current
63629-1604	Phendimetrazine Tartrate	Phendimetrazine Tartrate	bryant ranch prepack	ANDA	Current
63629-2489	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Bryant Ranch Prepack	ANDA	Current
63629-2489	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Bryant Ranch Prepack	ANDA	Current
63629-7266	Phendimetrazine Tartrate	Phendimetrazine Tartrate	Bryant Ranch Prepack	ANDA	Current
63629-7266	Phendimetrazine Tartrate	Phendimetrazine Tartrate	Bryant Ranch Prepack	ANDA	Current
63629-8536	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Bryant Ranch Prepack	ANDA	Current
68071-2605	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2605	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2605	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3062	Phendimetrazine Tartrate	Phendimetrazine Tartrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3062	Phendimetrazine Tartrate	Phendimetrazine Tartrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3062	Phendimetrazine Tartrate	Phendimetrazine Tartrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-9743	Phendimetrazine Tartrate	Phendimetrazine Tartrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9743	Phendimetrazine Tartrate	Phendimetrazine Tartrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
69543-410	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-410	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Virtus Pharmaceuticals, L	ANDA	Current
71335-1840	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Bryant Ranch Prepack	ANDA	Current