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): 202349
Company: WATSON LABS INC

Products on ANDA 202349

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL VALERATE AND DIENOGEST	DIENOGEST; ESTRADIOL VALERATE	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202349

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2017	ORIG-1	Tentative Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 202349

ESTRADIOL VALERATE AND DIENOGEST

TABLET;ORAL; N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL VALERATE AND DIENOGEST	DIENOGEST; ESTRADIOL VALERATE	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET;ORAL	Prescription	No	AB	202349	WATSON LABS INC

Top