Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202727
Company: WOCKHARDT LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Over-the-counter None 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
05/18/2012 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202727s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202727Orig1s000.pdf

LANSOPRAZOLE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE, DELAYED REL PELLETS;ORAL; 15MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Over-the-counter No 202194 DR REDDYS LABS LTD
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Over-the-counter No 207157 KREMERS URBAN PHARMS
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Over-the-counter No 203187 MYLAN PHARMS INC
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Over-the-counter No 203306 NATCO PHARMA LTD
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Over-the-counter No 202319 PERRIGO R AND D
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Over-the-counter No 202727 WOCKHARDT LTD
PREVACID 24 HR LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Over-the-counter Yes 022327 GLAXOSMITHKLINE CONS

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