Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020472
Company: PFIZER
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/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 |
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 |