Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084951
Company: MONARCH PHARMS

Products on ANDA 084951

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MENEST	ESTROGENS, ESTERIFIED	0.3MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084951

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
02/15/2024	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
04/08/2019	SUPPL-24	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/01/2004	SUPPL-20	Labeling		Label is not available on this site.
12/05/2001	SUPPL-17	Labeling		Label is not available on this site.
12/05/2001	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/05/2001	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
12/05/2001	SUPPL-14	Manufacturing (CMC)-Manufacturing Process		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.
05/10/1990	SUPPL-9	Labeling		Label is not available on this site.
06/02/1982	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.