Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203448
Company: LUPIN LTD

Products on ANDA 203448

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KAITLIB FE	ETHINYL ESTRADIOL; NORETHINDRONE	0.025MG;0.8MG	TABLET, CHEWABLE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203448

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2015	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
05/06/2024	SUPPL-5	Labeling-Container/Carton Labels		Label is not available on this site.
05/06/2024	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203448

KAITLIB FE

TABLET, CHEWABLE;ORAL; 0.025MG;0.8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KAITLIB FE	ETHINYL ESTRADIOL; NORETHINDRONE	0.025MG;0.8MG	TABLET, CHEWABLE;ORAL	Prescription	No	AB	203448	LUPIN LTD
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	0.025MG;0.8MG	TABLET, CHEWABLE;ORAL	Prescription	Yes	AB	022573	TEVA BRANDED PHARM
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE	0.025MG;0.8MG	TABLET, CHEWABLE;ORAL	Prescription	No	AB	203371	XIROMED