Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205675
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;IV (INFUSION) Prescription AP 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
03/30/2016 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
03/19/2021 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

04/20/2020 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

09/17/2019 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

09/17/2019 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/17/2019 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

09/17/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/17/2019 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

PANTOPRAZOLE SODIUM

INJECTABLE;IV (INFUSION); EQ 40MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;IV (INFUSION) Prescription No AP 209524 ACIC PHARMS
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;IV (INFUSION) Prescription No AP 079197 AKORN
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;IV (INFUSION) Prescription No AP 205675 AUROBINDO PHARMA LTD
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;IV (INFUSION) Prescription No AP 090296 SANDOZ INC
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;IV (INFUSION) Prescription No AP 077674 SUN PHARM
PROTONIX IV PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;IV (INFUSION) Prescription Yes AP 020988 WYETH PHARMS

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