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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040766
Company: IPCA LABS LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;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
06/14/2007 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
01/24/2024 SUPPL-27 Labeling-Package Insert

Label is not available on this site.
01/24/2024 SUPPL-24 Labeling-Package Insert

Label is not available on this site.
11/10/2022 SUPPL-21 Labeling-Package Insert

Label is not available on this site.
11/10/2022 SUPPL-20 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
08/23/2021 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
03/31/2020 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040766Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040766Orig1s013ltr.pdf
02/20/2008 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/31/2020 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040766Orig1s013lbl.pdf

HYDROXYCHLOROQUINE SULFATE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 213342 ACCORD HLTHCARE
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 201691 ALKALOIDA ZRT
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 210577 AMNEAL PHARMS CO
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 210441 APPCO
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040274 AUROBINDO PHARMA USA
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 210543 CHARTWELL RX
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040150 CREEKWOOD PHARMS
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040766 IPCA LABS LTD
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 210959 LAURUS
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040104 SANDOZ
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 212902 SENORES PHARMS
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040081 TEVA PHARMS
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040657 ZYDUS PHARMS USA INC
PLAQUENIL HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription Yes AB 009768 CONCORDIA
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