Application 074425

Type: ANDA
Sponsor: MYLAN

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 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
A074425-001	PENTOXIFYLLINE	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		1997-07-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074425-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074425-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074425-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074425-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074425-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074425-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074425-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074425-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074425-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074425-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074425-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074425-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074425-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074425-001	AB	1	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074425-001	AB	1	`a50c72e98297…`

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 · 2 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	Exact identifier application applno (ANDA): 074425 application number: ANDA074425
Pentoxifylline	PENTOXIFYLLINE	Bryant Ranch Prepack	c3ad4fb4-8995-46ab-86e9-7ec67ef607f9	2025-04-07	Adverse reactions	Exact identifier application applno (ANDA): 074425 application number: ANDA074425

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0357	Pentoxifylline	Pentoxifylline	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0357	Pentoxifylline	Pentoxifylline	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-4523	Pentoxifylline	Pentoxifylline	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
51079-889	Pentoxifylline	Pentoxifylline	Mylan Institutional Inc.	ANDA	Current
53808-0758	Pentoxifylline	Pentoxifylline	State of Florida DOH Central Pharmacy	ANDA	Current