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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021443
Company: ASPEN

Products on NDA 021443

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	0.3MG	TABLET;ORAL	Discontinued	None	No	No
ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	0.45MG	TABLET;ORAL	Discontinued	None	No	No
ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	0.625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	No	No
ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	No	No
ENJUVIA	ESTROGENS, CONJUGATED SYNTHETIC B	0.9MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021443

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/10/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021443lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21443ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021443s000_EnjuviaTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021443s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021443Orig1s013ltr.pdf
11/30/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021443s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021443Orig1s011, s012ltr.pdf
11/30/2020	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021443s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021443Orig1s011, s012ltr.pdf
11/01/2017	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021443s010lbl.pdf
06/30/2015	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021443s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021443Orig1s009ltr.pdf
04/27/2007	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021443s005ltr.pdf
04/23/2007	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021443s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021443s004ltr.pdf

Labels for NDA 021443

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021443s013lbl.pdf
11/30/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021443s011s012lbl.pdf
11/30/2020	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021443s011s012lbl.pdf
11/01/2017	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021443s010lbl.pdf
06/30/2015	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021443s009lbl.pdf
04/23/2007	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021443s004lbl.pdf
05/10/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021443lbl.pdf

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