Application 075028

Type: ANDA
Sponsor: VALEANT PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PENTOXIFYLLINE	PENTOXIFYLLINE	TABLET, EXTENDED RELEASE;ORAL	400MG	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
A075028-001	PENTOXIFYLLINE	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL			1998-07-20

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1998-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1998-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A075028-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075028-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075028-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075028-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075028-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075028-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075028-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075028-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075028-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075028-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075028-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075028-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075028-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075028-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075028-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075028-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075028-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075028-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075028-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075028-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075028-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075028-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075028-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075028-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075028-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075028-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075028-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075028-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075028-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075028-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075028-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075028-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075028-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075028-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075028-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075028-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075028-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075028-001	AB	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pentoxifylline	PENTOXIFYLLINE	Rising Pharma Holdings, Inc.	cd840a2c-2a0e-4b2b-84ff-a0406bb6fa37	2026-05-15	Adverse reactions	Name fallback brand name: Pentoxifylline generic name: PENTOXIFYLLINE
Pentoxifylline	PENTOXIFYLLINE	ANI Pharmaceuticals, Inc.	9ca79c97-e4e5-4297-85eb-7a9b3d8083b5	2025-11-07	Adverse reactions	Name fallback brand name: Pentoxifylline generic name: PENTOXIFYLLINE
PENTOXIFYLLINE	PENTOXIFYLLINE	Major Pharmaceuticals	59c9a583-1f93-480f-879c-457a574374da	2025-09-22	Adverse reactions	Name fallback brand name: PENTOXIFYLLINE generic name: PENTOXIFYLLINE
PENTOXIFYLLINE	PENTOXIFYLLINE	Bryant Ranch Prepack	84816505-9253-41cf-8894-2b2d0e4aff67	2025-09-04	Adverse reactions	Name fallback brand name: PENTOXIFYLLINE generic name: PENTOXIFYLLINE
PENTOXIFYLLINE	PENTOXIFYLLINE	Apotex Corp.	40ae2d9a-0d95-640d-0640-f76e7e1a13cb	2025-08-21	Adverse reactions	Name fallback brand name: PENTOXIFYLLINE generic name: PENTOXIFYLLINE
Pentoxifylline	PENTOXIFYLLINE	Bryant Ranch Prepack	c3ad4fb4-8995-46ab-86e9-7ec67ef607f9	2025-04-07	Adverse reactions	Name fallback brand name: Pentoxifylline generic name: PENTOXIFYLLINE
Pentoxifylline	PENTOXIFYLLINE	NCS HealthCare of KY, LLC dba Vangard Labs	bd2f2672-62cd-4e77-8b0b-782f5d06198b	2024-10-22	Adverse reactions	Name fallback brand name: Pentoxifylline generic name: PENTOXIFYLLINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43353-123	Pentoxifylline	Pentoxifylline	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-123	Pentoxifylline	Pentoxifylline	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68071-4532	Pentoxifylline	Pentoxifylline	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4532	Pentoxifylline	Pentoxifylline	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4532	Pentoxifylline	Pentoxifylline	NuCare Pharmaceuticals,Inc.	ANDA	Current
68682-101	Pentoxifylline	Pentoxifylline	Oceanside Pharmaceuticals	ANDA	Current
68682-101	Pentoxifylline	Pentoxifylline	Oceanside Pharmaceuticals	ANDA	Current
68682-101	Pentoxifylline	Pentoxifylline	Oceanside Pharmaceuticals	ANDA	Current
68682-101	Pentoxifylline	Pentoxifylline	Oceanside Pharmaceuticals	ANDA	Current
68682-101	Pentoxifylline	Pentoxifylline	Oceanside Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42923	ORIG	1998-07-20
30734	ORIG	1998-07-20