Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074755
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.02% SOLUTION;INHALATION Discontinued None 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
01/10/1997 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/07/2012 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/074755Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/074755Orig1s025ltr.pdf
02/20/2007 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/26/2004 SUPPL-15 Labeling

Label is not available on this site.

04/01/2004 SUPPL-13 Labeling

Label is not available on this site.

12/20/2002 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/20/2002 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/2001 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/24/2000 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/24/2000 SUPPL-3 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/14/1997 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/07/2012 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/074755Orig1s025lbl.pdf

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