Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084948
Company: MONARCH PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MENEST ESTROGENS, ESTERIFIED 0.625MG TABLET;ORAL Prescription None 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
09/28/1977 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
04/08/2019 SUPPL-23 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/01/2004 SUPPL-19 Labeling

Label is not available on this site.

02/07/2006 SUPPL-17 Labeling

Label is not available on this site.

04/28/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/18/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/13/1992 SUPPL-10 Labeling

Label is not available on this site.

03/28/1990 SUPPL-9 Labeling

Label is not available on this site.

06/21/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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