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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203339
Company: LUPIN

Products on ANDA 203339

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMABELZ	ESTRADIOL; NORETHINDRONE ACETATE	0.5MG;0.1MG	TABLET;ORAL	Prescription	BX	No	No
AMABELZ	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	BX	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203339

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/2016	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
03/15/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/21/2017	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203339

AMABELZ

There are no Therapeutic Equivalents.

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