Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091688
Company: INVAGEN PHARMS
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
08/23/2016 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/23/2016 SUPPL-1

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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