Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077975
Company: SUN PHARM INDUSTRIES

Products on ANDA 077975

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077975

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/11/2009	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077975s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077975s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/16/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 077975

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077975s000lbl.pdf