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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040274
Company: AUROBINDO PHARMA USA

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
05/29/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-274_Hydroxychloroquine%20Sulfate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40274ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040274_hydroxychloroqine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/11/2022 SUPPL-20 Labeling-Package Insert

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

Label is not available on this site.
04/09/2020 SUPPL-15 Labeling-Container/Carton Labels

Label is not available on this site.
04/01/2020 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040274Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040274Orig1s013ltr.pdf
01/20/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
09/10/2002 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/01/2020 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040274Orig1s013lbl.pdf
05/29/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-274_Hydroxychloroquine%20Sulfate_Prntlbl.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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