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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074878
Company: ANI PHARMS

Products on ANDA 074878

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENTOXIFYLLINE	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074878

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/09/1997	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2001	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
03/30/2001	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
07/07/2000	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
02/16/2000	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
02/16/2000	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
02/16/2000	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/28/2000	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/21/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/06/1998	SUPPL-2	Labeling		Label is not available on this site.
03/02/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074878

PENTOXIFYLLINE

TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PENTOXIFYLLINE	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	074878	ANI PHARMS
PENTOXIFYLLINE	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075191	APOTEX
PENTOXIFYLLINE	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075028	VALEANT PHARMS

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