Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077255
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB No No
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;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
11/10/2009 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077255s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/02/2015 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/30/2013 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/30/2013 SUPPL-11 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

04/16/2012 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

04/18/2012 SUPPL-8 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

04/18/2012 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/18/2012 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

04/18/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

LANSOPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203957 AJANTA PHARMA LTD
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091269 DR REDDYS LABS LTD
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205868 INVENTIA HLTHCARE
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 207156 KREMERS URBAN PHARMS
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091212 KRKA TOVARNA ZDRAVIL
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203203 LABS LICONSA
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090763 MYLAN PHARMS INC
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 201921 NATCO PHARMA LTD
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090331 SANDOZ
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 202637 SUN PHARM INDS LTD
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 077255 TEVA PHARMS
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 202176 WOCKHARDT USA
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 202366 ZYDUS HLTHCARE
PREVACID LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription Yes AB 020406 TAKEDA PHARMS USA

CAPSULE, DELAYED REL PELLETS;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203957 AJANTA PHARMA LTD
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091269 DR REDDYS LABS LTD
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205868 INVENTIA HLTHCARE
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 207156 KREMERS URBAN PHARMS
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091212 KRKA TOVARNA ZDRAVIL
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203203 LABS LICONSA
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090763 MYLAN PHARMS INC
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 201921 NATCO PHARMA LTD
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090331 SANDOZ
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091509 SUN PHARM INDS LTD
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 077255 TEVA PHARMS
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 202176 WOCKHARDT USA
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 202366 ZYDUS HLTHCARE
PREVACID LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription Yes AB 020406 TAKEDA PHARMS USA

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