Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091692
Company: NOVAST LABS

Products on ANDA 091692

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOLISHALE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.09MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091692

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/22/2020	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
04/29/2022	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091692

DOLISHALE

TABLET;ORAL; 0.02MG;0.09MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOLISHALE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.09MG	TABLET;ORAL	Prescription	No	AB	091692	NOVAST LABS
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.09MG	TABLET;ORAL	Prescription	No	AB	202791	GLENMARK PHARMS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.09MG	TABLET;ORAL	Prescription	No	AB	079218	WATSON LABS