Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020655
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALORA | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
ALORA | ESTRADIOL | 0.075MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
ALORA | ESTRADIOL | 0.1MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
ALORA | ESTRADIOL | 0.025MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/20/1996 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020655s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020655Orig1s023ltr.pdf | |
11/01/2017 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020655s020lbl.pdf | |
03/30/2020 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020655Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020655Orig1s019ltr.pdf | |
08/30/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/19/2005 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020655s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020655s011ltr.pdf | |
04/05/2002 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20655s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20655s8ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-665s008_Alora.cfm | |
10/02/2001 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/18/2003 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20655slr006_alora_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20655slr006ltr.pdf | |
04/14/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
06/04/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
11/24/1998 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
04/22/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/06/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020655s023lbl.pdf | |
03/30/2020 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020655Orig1s019lbl.pdf | |
11/01/2017 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020655s020lbl.pdf | |
05/19/2005 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020655s011lbl.pdf | |
11/18/2003 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20655slr006_alora_lbl.pdf | |
04/05/2002 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20655s8lbl.pdf |