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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020472
Company: PFIZER

Products on NDA 020472

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRING	ESTRADIOL	0.0075MG/24HR	INSERT, EXTENDED RELEASE;VAGINAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020472

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/1996	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020472Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020472s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020472Orig1s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020472Orig1s020ltr.pdf
07/27/2022	SUPPL-19	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020472Orig1s019Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020472Orig1s019ltr.pdf
11/01/2017	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020472s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020472Orig1s016ltr.pdf
09/29/2015	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020472s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020472Orig1s012,s013ltr.pdf
09/29/2015	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020472s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020472Orig1s012,s013ltr.pdf
08/12/2014	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020472s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020472Orig1s011ltr.pdf
05/16/2014	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/25/2008	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020472s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020472s007ltr.pdf
07/24/2001	SUPPL-4	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020472_s004_ESTRING 2 MG.pdf
01/05/2000	SUPPL-3	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020472_s003_ESTRING 2 MG.pdf
04/18/1997	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
05/16/2000	SUPPL-1	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020472_s001_ESTRING 2 MG.pdf

Labels for NDA 020472

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020472s020lbl.pdf
07/27/2022	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020472Orig1s019Lbl.pdf
07/27/2022	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020472Orig1s019Lbl.pdf
11/01/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020472s016lbl.pdf
09/29/2015	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020472s012s013lbl.pdf
09/29/2015	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020472s012s013lbl.pdf
08/12/2014	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020472s011lbl.pdf
08/25/2008	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020472s007lbl.pdf

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