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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090610
Company: IPCA LABS LTD

Products on ANDA 090610

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLOROQUINE PHOSPHATE	CHLOROQUINE PHOSPHATE	250MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090610

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/2009	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
07/24/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/03/2022	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
03/17/2022	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
03/26/2020	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/090610Orig1s004,s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/090610Orig1s004,s005ltr.pdf
03/26/2020	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/090610Orig1s004,s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/090610Orig1s004,s005ltr.pdf
02/12/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 090610

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/090610Orig1s004,s005lbl.pdf
03/26/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/090610Orig1s004,s005lbl.pdf
03/26/2020	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/090610Orig1s004,s005lbl.pdf

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