Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075434
Company: FOSUN PHARMA

Products on ANDA 075434

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075434

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/08/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-434_Naltrexone%20Hydrochloride_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75434ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-434_Naltrexone.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/11/2011	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
08/11/2000	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for ANDA 075434

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-434_Naltrexone%20Hydrochloride_prntlbl.pdf