Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009768
Company: CONCORDIA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PLAQUENIL HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/18/1955 ORIG-1 Approval Type 1 - New Molecular Entity 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
01/05/2019 SUPPL-51 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/009768Orig1s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/009768Orig1s051ltr.pdf
01/27/2017 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009768Orig1s037,s045,s047ltr.pdf
01/27/2017 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009768Orig1s037,s045,s047ltr.pdf
06/20/2007 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009768s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009768s041ltr.pdf
01/27/2017 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009768Orig1s037,s045,s047ltr.pdf
05/02/2002 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

02/07/2002 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/05/2000 SUPPL-33 Labeling

Label is not available on this site.

10/02/1996 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1994 SUPPL-29 Labeling

Label is not available on this site.

02/14/1991 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1991 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1990 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/04/1989 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1988 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1988 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/1986 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/22/1985 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/05/1985 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1987 SUPPL-17 Labeling

Label is not available on this site.

11/01/1984 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1983 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1982 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1982 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/02/1987 SUPPL-11 Labeling

Label is not available on this site.

05/15/1981 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/19/1980 SUPPL-9 Labeling

Label is not available on this site.

04/29/1976 SUPPL-7 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/05/2019 SUPPL-51 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/009768Orig1s051lbl.pdf
01/05/2019 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/009768Orig1s051lbl.pdf
01/27/2017 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf
01/27/2017 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf
01/27/2017 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf
06/20/2007 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009768s041lbl.pdf

PLAQUENIL

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 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 040760 HIKMA 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 LABS LTD
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040274 MYLAN
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040104 SANDOZ
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040081 TEVA PHARMS
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 210441 TWI PHARMS
HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE 200MG TABLET;ORAL Prescription No AB 040133 WATSON LABS
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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