Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080880
Company: IMPAX LABS

Products on ANDA 080880

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 080880

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/11/1974	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
02/02/2024	SUPPL-69	Labeling-Package Insert		Label is not available on this site.
07/24/2023	SUPPL-68	Labeling-Package Insert		Label is not available on this site.
05/03/2022	SUPPL-66	Labeling-Package Insert		Label is not available on this site.
03/17/2022	SUPPL-65	Labeling-Package Insert		Label is not available on this site.
04/30/2020	SUPPL-63	Labeling-Package Insert		Label is not available on this site.
07/18/1997	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
10/11/1996	SUPPL-43	Labeling		Label is not available on this site.
12/15/1988	SUPPL-40	Labeling		Label is not available on this site.
11/22/1988	SUPPL-39	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 080880

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