Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090249
Company: IPCA LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE 500MG TABLET;ORAL Prescription AA 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
12/03/2009 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
03/24/2020 SUPPL-4 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/090249Orig1s003,s004ltr.pdf
03/24/2020 SUPPL-3 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/090249Orig1s003,s004ltr.pdf
08/28/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

CHLOROQUINE PHOSPHATE

TABLET;ORAL; 500MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE 500MG TABLET;ORAL Prescription No AA 083082 HIKMA PHARMS
CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE 500MG TABLET;ORAL Prescription No AA 090249 IPCA LABS LTD
CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE 500MG TABLET;ORAL Prescription No AA 090612 NATCO PHARMA LTD

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