Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040114
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTRADIOL ESTRADIOL 1MG TABLET;ORAL Prescription AB No No
ESTRADIOL ESTRADIOL 2MG TABLET;ORAL Prescription AB No No
ESTRADIOL ESTRADIOL 0.5MG 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
03/14/1996 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
01/31/2019 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

02/21/2007 SUPPL-13 Labeling

Label is not available on this site.

07/15/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

09/05/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/2000 SUPPL-5 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/13/1999 SUPPL-4 Labeling

Label is not available on this site.

11/10/1999 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/20/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

ESTRADIOL

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 1MG TABLET;ORAL Prescription No AB 040197 BARR LABS INC
ESTRADIOL ESTRADIOL 1MG TABLET;ORAL Prescription No AB 040275 EPIC PHARMA INC
ESTRADIOL ESTRADIOL 1MG TABLET;ORAL Prescription No AB 040114 MAYNE PHARMA
ESTRADIOL ESTRADIOL 1MG TABLET;ORAL Prescription No AB 040326 MYLAN

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 2MG TABLET;ORAL Prescription No AB 040197 BARR LABS INC
ESTRADIOL ESTRADIOL 2MG TABLET;ORAL Prescription No AB 040275 EPIC PHARMA INC
ESTRADIOL ESTRADIOL 2MG TABLET;ORAL Prescription No AB 040114 MAYNE PHARMA
ESTRADIOL ESTRADIOL 2MG TABLET;ORAL Prescription No AB 040326 MYLAN

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.5MG TABLET;ORAL Prescription No AB 040197 BARR LABS INC
ESTRADIOL ESTRADIOL 0.5MG TABLET;ORAL Prescription No AB 040275 EPIC PHARMA INC
ESTRADIOL ESTRADIOL 0.5MG TABLET;ORAL Prescription No AB 040114 MAYNE PHARMA
ESTRADIOL ESTRADIOL 0.5MG TABLET;ORAL Prescription No AB 040326 MYLAN

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