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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074520
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP;ORAL Prescription AA 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
03/29/1996 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
11/02/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/20/2010 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

07/11/2001 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/04/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/04/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

OXYBUTYNIN CHLORIDE

SYRUP;ORAL; 5MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP;ORAL Prescription No AA 074520 LANNETT CO INC
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP;ORAL Prescription No AA 075137 PHARM ASSOC
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