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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091573
Company: PADAGIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TROSPIUM CHLORIDE TROSPIUM CHLORIDE 20MG TABLET;ORAL Prescription AB 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
11/17/2010 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
08/29/2013 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
08/01/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
03/31/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

TROSPIUM CHLORIDE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TROSPIUM CHLORIDE TROSPIUM CHLORIDE 20MG TABLET;ORAL Prescription No AB 091513 APOTEX
TROSPIUM CHLORIDE TROSPIUM CHLORIDE 20MG TABLET;ORAL Prescription No AB 091575 GLENMARK PHARMS LTD
TROSPIUM CHLORIDE TROSPIUM CHLORIDE 20MG TABLET;ORAL Prescription No AB 204945 HERITAGE PHARMS INC
TROSPIUM CHLORIDE TROSPIUM CHLORIDE 20MG TABLET;ORAL Prescription No AB 091688 INVAGEN PHARMS
TROSPIUM CHLORIDE TROSPIUM CHLORIDE 20MG TABLET;ORAL Prescription No AB 206472 MACLEODS PHARMS LTD
TROSPIUM CHLORIDE TROSPIUM CHLORIDE 20MG TABLET;ORAL Prescription No AB 091573 PADAGIS US
TROSPIUM CHLORIDE TROSPIUM CHLORIDE 20MG TABLET;ORAL Prescription No AB 215781 ZAMEER PHARMS
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