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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075028
Company: VALEANT PHARMS

Products on ANDA 075028

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 075028

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/1998	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75028_Pentoxifyline.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/02/2017	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
02/02/2017	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/02/2017	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
12/07/2006	SUPPL-9	Labeling		Label is not available on this site.
02/20/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
08/21/2001	SUPPL-5	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
08/21/2001	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/30/2000	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
06/11/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/11/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 075028

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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