Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040114
Company: RUBICON RESEARCH

Products on ANDA 040114

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL	ESTRADIOL	1MG	TABLET;ORAL	Discontinued	None	No	No
ESTRADIOL	ESTRADIOL	2MG	TABLET;ORAL	Discontinued	None	No	No
ESTRADIOL	ESTRADIOL	0.5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040114

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
02/16/2024	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
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.