Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040516
Company: IMPAX LABS

Products on ANDA 040516

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLOROQUINE PHOSPHATE	CHLOROQUINE PHOSPHATE	500MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040516

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2003	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-16	Labeling-Package Insert		Label is not available on this site.
05/03/2022	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
03/16/2022	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/28/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040516

CHLOROQUINE PHOSPHATE

TABLET;ORAL; 500MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHLOROQUINE PHOSPHATE	CHLOROQUINE PHOSPHATE	500MG	TABLET;ORAL	Prescription	No	AA	040516	IMPAX LABS
CHLOROQUINE PHOSPHATE	CHLOROQUINE PHOSPHATE	500MG	TABLET;ORAL	Prescription	No	AA	090249	IPCA LABS LTD
CHLOROQUINE PHOSPHATE	CHLOROQUINE PHOSPHATE	500MG	TABLET;ORAL	Prescription	No	AA	090612	NATCO PHARMA LTD
CHLOROQUINE PHOSPHATE	CHLOROQUINE PHOSPHATE	500MG	TABLET;ORAL	Prescription	No	AA	214756	SUVEN PHARMS