Application 075199

Type: ANDA
Sponsor: ANI PHARMS INC

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 44.

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
A075199-001	PENTOXIFYLLINE	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL			1999-09-03

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A075199-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	1999-09-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075199-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	1999-09-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075199-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	1999-09-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075199-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	1999-09-03	`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 · 6 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	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

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53808-0757	Pentoxifylline	PENTOXIFYLLINE	State of Florida DOH Central Pharmacy	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8560	ORIG	1999-09-03