Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076644
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
11/09/2006 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076644s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2005/076644Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/05/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

01/05/2016 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

07/26/2013 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

04/29/2013 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

03/01/2011 SUPPL-11 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

03/20/2009 SUPPL-9 Labeling

Label is not available on this site.

OXYBUTYNIN CHLORIDE

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English