Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204010
Company: AMNEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 15MG TABLET, EXTENDED RELEASE;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
11/23/2015 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
08/19/2019 SUPPL-7 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

08/19/2019 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

OXYBUTYNIN CHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DITROPAN XL OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020897 JANSSEN PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207138 ACCORD HLTHCARE
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211655 AJANTA PHARMA LTD
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204010 AMNEAL PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076745 IMPAX PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076702 MYLAN
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078503 OSMOTICA PHARM US
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206121 UNIQUE PHARM LABS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202332 ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DITROPAN XL OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020897 JANSSEN PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207138 ACCORD HLTHCARE
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211655 AJANTA PHARMA LTD
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204010 AMNEAL PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076745 IMPAX PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076644 MYLAN PHARMS INC
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078503 OSMOTICA PHARM US
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206121 UNIQUE PHARM LABS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202332 ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207138 ACCORD HLTHCARE
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211655 AJANTA PHARMA LTD
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204010 AMNEAL PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076745 IMPAX PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076644 MYLAN PHARMS INC
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078503 OSMOTICA PHARM US
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206121 UNIQUE PHARM LABS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202332 ZYDUS PHARMS

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