Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091575
Company: GLENMARK GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TROSPIUM CHLORIDE TROSPIUM CHLORIDE 20MG TABLET;ORAL Prescription AB No 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
08/13/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091575s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/31/2013 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

07/31/2013 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

11/30/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/31/2012 SUPPL-3 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 GENERICS
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 091573 PADDOCK LLC

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