Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019715
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPENTUM OLSALAZINE SODIUM 250MG CAPSULE;ORAL Prescription None Yes 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
07/31/1990 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/05/2009 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019715s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019715s027ltr.pdf
07/10/2007 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019715s025ltr.pdf
11/12/2002 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/09/2002 SUPPL-21 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19715scs021ltr.pdf
02/14/2001 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/08/2000 SUPPL-19 Labeling

Label is not available on this site.

01/18/2002 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19715s18ltr.pdf
06/30/1999 SUPPL-17 Labeling

Label is not available on this site.

06/06/1996 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/11/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/29/1996 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1995 SUPPL-13 Labeling

Label is not available on this site.

01/31/1996 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/12/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/23/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/04/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/22/1994 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/24/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/08/1993 SUPPL-5 Labeling

Label is not available on this site.

01/26/1995 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/15/1993 SUPPL-3 Labeling

Label is not available on this site.

01/05/1993 SUPPL-2 Labeling

Label is not available on this site.

08/09/1993 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/05/2009 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019715s027lbl.pdf

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