Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040009
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 40MG TABLET, EXTENDED RELEASE;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/30/1998 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-009_Isosorbide%20Dinitrate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-009_Isosorbide.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/19/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/07/2002 SUPPL-2 Labeling

Label is not available on this site.

04/23/2001 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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