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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040104
Company: SANDOZ

Products on ANDA 040104

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040104

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/1995	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
09/05/2024	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
09/05/2024	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
09/05/2024	SUPPL-36	Labeling-Package Insert		Label is not available on this site.
08/23/2021	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
04/01/2020	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040104Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040104Orig1s025ltr.pdf
11/28/2007	SUPPL-15	Labeling		Label is not available on this site.
04/19/2002	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
05/09/2001	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
03/13/2001	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
02/17/2000	SUPPL-7	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/20/1999	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
02/11/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/25/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/05/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/15/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/15/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 040104

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/01/2020	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040104Orig1s025lbl.pdf

Therapeutic Equivalents for ANDA 040104

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	ADVANZ PHARMA

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