Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021438
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INNOPRAN XL PROPRANOLOL HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription BX No No
INNOPRAN XL PROPRANOLOL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription BX No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/12/2003 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-438_Innopran_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21438ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-438_Innopran.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/19/2013 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021438s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021438Orig1s016ltr.pdf
12/14/2010 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021438s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021438s013,s014ltr.pdf
12/14/2010 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021438s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021438s013,s014ltr.pdf
12/30/2009 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021438s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021438s012ltr.pdf
01/02/2008 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021438s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021438s01ltr_rc.pdf
10/22/2004 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21438s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/19/2013 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021438s016lbl.pdf
12/14/2010 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021438s013s014lbl.pdf
12/14/2010 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021438s013s014lbl.pdf
12/30/2009 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021438s012lbl.pdf
01/02/2008 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021438s011lbl.pdf
03/12/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-438_Innopran_prntlbl.pdf

INNOPRAN XL

There are no Therapeutic Equivalents.

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