Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020472
Company: PFIZER
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
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/2018/020472Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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