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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210441
Company: APPCO

Products on ANDA 210441

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
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET;ORAL	Prescription	AB	No	No
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET;ORAL	Prescription	AB	No	No
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210441

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2018	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210441Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210441Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/29/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
07/07/2022	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
09/19/2022	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
04/27/2022	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 210441

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210441Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 210441

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

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET;ORAL	Prescription	No	AB	213342	ACCORD HLTHCARE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET;ORAL	Prescription	No	AB	210441	APPCO

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET;ORAL	Prescription	No	AB	213342	ACCORD HLTHCARE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET;ORAL	Prescription	No	AB	210441	APPCO

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET;ORAL	Prescription	No	AB	213342	ACCORD HLTHCARE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET;ORAL	Prescription	No	AB	210441	APPCO

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