Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202349
Company: WATSON LABS INC
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
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.

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

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