Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091269
Company: DR REDDYS LABS LTD
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
10/15/2010 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
05/10/2019 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/10/2019 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

05/10/2019 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/10/2019 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

05/10/2019 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/03/2015 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/31/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/02/2013 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

05/11/2012 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

01/31/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

01/31/2012 SUPPL-1 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 207394 ALKEM LABS 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 203203 LABS LICONSA
LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 207156 LANNETT CO INC
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
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 207394 ALKEM LABS 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 203203 LABS LICONSA
LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 207156 LANNETT CO INC
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
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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