Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074962
Company: UPSHER SMITH LABS

Products on ANDA 074962

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENTOXIL	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074962

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-962_Pentoxifylline_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74962ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-962_pentoxifylline.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/30/2005	SUPPL-8	Labeling		Label is not available on this site.
10/29/2004	SUPPL-5	Labeling		Label is not available on this site.
12/19/2002	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
04/21/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
04/21/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 074962

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-962_Pentoxifylline_prntlbl.pdf