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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075960
Company: ACTAVIS ELIZABETH

Products on ANDA 075960

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075960

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/2002	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/N75960lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75960ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/06/2008	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
08/22/2005	SUPPL-5	Labeling		Label is not available on this site.
10/17/2002	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 075960

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/19/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/N75960lbl.pdf

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