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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206121
Company: UNIQUE PHARM LABS
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
05/27/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2020 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

08/19/2019 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/19/2019 SUPPL-2 Labeling-Container/Carton Labels, 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 210717 BIONPHARMA INC
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 214415 RUBICON
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 210717 BIONPHARMA 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 214415 RUBICON
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 210717 BIONPHARMA 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 214415 RUBICON
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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