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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091289
Company: ACTAVIS LABS FL INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TROSPIUM CHLORIDE TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE;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
10/12/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091289Orig1s000ltr.pdf

TROSPIUM CHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TROSPIUM CHLORIDE TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091289 ACTAVIS LABS FL INC
TROSPIUM CHLORIDE TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 214760 AMTA
TROSPIUM CHLORIDE TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 213185 GRANULES
TROSPIUM CHLORIDE TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 201291 PADAGIS US
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