An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200493
Company: MYLAN LABS LTD

Products on ANDA 200493

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200493

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2015	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/24/2023	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/24/2023	SUPPL-8	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
01/24/2019	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Proprietary Name Change		Label is not available on this site.
03/24/2023	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 200493

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

TABLET;ORAL; 0.02MG,0.1MG;0.01MG,N/A
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	091674	LUPIN LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	200493	MYLAN LABS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	205131	XIROMED
LO SIMPESSE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	206852	AUROBINDO PHARMA
LOSEASONIQUE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET;ORAL	Prescription	No	AB	022262	TEVA BRANDED PHARM

Top