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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074755
Company: MYLAN SPECIALITY LP

Products on ANDA 074755

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074755

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.

Labels for ANDA 074755

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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