Application 075191

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PENTOXIFYLLINE	PENTOXIFYLLINE	TABLET, EXTENDED RELEASE;ORAL	400MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075191-001	PENTOXIFYLLINE	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075191-001	AB

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075191-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075191-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075191-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075191-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075191-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075191-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075191-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075191-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075191-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075191-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075191-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075191-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075191-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075191-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075191-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075191-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075191-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075191-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075191-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075191-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075191-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075191-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075191-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075191-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075191-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075191-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075191-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075191-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075191-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075191-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075191-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075191-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075191-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075191-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075191-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075191-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075191-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075191-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075191-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075191-001	AB	1	`e64feba35796…`

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
PENTOXIFYLLINE	PENTOXIFYLLINE	Major Pharmaceuticals	59c9a583-1f93-480f-879c-457a574374da	2025-09-22	Adverse reactions	Exact identifier application applno (ANDA): 075191 application number: ANDA075191 ndc (product): 0904-5448
PENTOXIFYLLINE	PENTOXIFYLLINE	Bryant Ranch Prepack	84816505-9253-41cf-8894-2b2d0e4aff67	2025-09-04	Adverse reactions	Exact identifier application applno (ANDA): 075191 application number: ANDA075191 ndc (product): 63629-2910
PENTOXIFYLLINE	PENTOXIFYLLINE	Apotex Corp.	40ae2d9a-0d95-640d-0640-f76e7e1a13cb	2025-08-21	Adverse reactions	Exact identifier application applno (ANDA): 075191 application number: ANDA075191 ndc (product): 60505-0033

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8305	PENTOXIFYLLINE	PENTOXIFYLLINE	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8305	PENTOXIFYLLINE	PENTOXIFYLLINE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-5448	PENTOXIFYLLINE	PENTOXIFYLLINE	Major Pharmaceuticals	ANDA	Current
0904-5448	PENTOXIFYLLINE	PENTOXIFYLLINE	Major Pharmaceuticals	ANDA	Current
33261-992	PENTOXIFYLLINE	PENTOXIFYLLINE	Aidarex Pharmaceuticals LLC	ANDA	Current
53808-0516	Pentoxifylline	Pentoxifylline	State of Florida DOH Central Pharmacy	ANDA	Current
60429-703	PENTOXIFYLLINE	PENTOXIFYLLINE	Golden State Medical Supply, Inc.	ANDA	Current
60429-703	PENTOXIFYLLINE	PENTOXIFYLLINE	Golden State Medical Supply, Inc.	ANDA	Current
60505-0033	PENTOXIFYLLINE	PENTOXIFYLLINE	Apotex Corp.	ANDA	Current
60505-0033	PENTOXIFYLLINE	PENTOXIFYLLINE	Apotex Corp.	ANDA	Current
60505-0033	PENTOXIFYLLINE	PENTOXIFYLLINE	Apotex Corp.	ANDA	Current
63629-2910	PENTOXIFYLLINE	PENTOXIFYLLINE	Bryant Ranch Prepack	ANDA	Current
63629-2910	PENTOXIFYLLINE	PENTOXIFYLLINE	Bryant Ranch Prepack	ANDA	Current
66267-710	PENTOXIFYLLINE	PENTOXIFYLLINE	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-710	PENTOXIFYLLINE	PENTOXIFYLLINE	NuCare Pharmaceuticals, Inc.	ANDA	Current
67544-252	PENTOXIFYLLINE	PENTOXIFYLLINE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68788-9742	PENTOXIFYLLINE	PENTOXIFYLLINE	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1285	PENTOXIFYLLINE	PENTOXIFYLLINE	REMEDYREPACK INC.	ANDA	Current
70518-1285	PENTOXIFYLLINE	PENTOXIFYLLINE	REMEDYREPACK INC.	ANDA	Current
70518-1285	PENTOXIFYLLINE	PENTOXIFYLLINE	REMEDYREPACK INC.	ANDA	Current
70518-1285	PENTOXIFYLLINE	PENTOXIFYLLINE	REMEDYREPACK INC.	ANDA	Current
70518-1285	PENTOXIFYLLINE	PENTOXIFYLLINE	REMEDYREPACK INC.	ANDA	Current
72189-025	PENTOXIFYLLINE	PENTOXIFYLLINE	Direct_Rx	ANDA	Current
72189-025	PENTOXIFYLLINE	PENTOXIFYLLINE	Direct_Rx	ANDA	Current
72189-025	PENTOXIFYLLINE	PENTOXIFYLLINE	Direct_Rx	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30791	ORIG	1999-06-09