An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	Prescription	AA	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

Therapeutic Equivalents for ANDA 090610

CHLOROQUINE PHOSPHATE

TABLET;ORAL; 250MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHLOROQUINE PHOSPHATE	CHLOROQUINE PHOSPHATE	250MG	TABLET;ORAL	Prescription	No	AA	080880	IMPAX LABS
CHLOROQUINE PHOSPHATE	CHLOROQUINE PHOSPHATE	250MG	TABLET;ORAL	Prescription	No	AA	090610	IPCA LABS LTD
CHLOROQUINE PHOSPHATE	CHLOROQUINE PHOSPHATE	250MG	TABLET;ORAL	Prescription	No	AA	091621	NATCO PHARMA LTD

Top