Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086069
Company: ALLERGAN
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESTRACE | ESTRADIOL | 0.01% | CREAM;VAGINAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 01/31/1984 | ORIG-1 | Approval |
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-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2022 | SUPPL-26 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/086069Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/086069Orig1s026ltr.pdf | |
| 08/15/2018 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/21/2017 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/17/2005 | SUPPL-18 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/86069s018lbl.pdf | |
| 03/27/2001 | SUPPL-17 | Manufacturing (CMC)-Facility |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/086069Orig1s017.pdf |
| 08/11/2000 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/11/2000 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/03/1998 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/09/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/14/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/07/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/11/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/16/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1986 | SUPPL-2 | 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 |
|---|---|---|---|---|---|
| 11/30/2022 | SUPPL-26 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/086069Orig1s026lbl.pdf | |
| 08/17/2005 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/86069s018lbl.pdf |
ESTRACE
CREAM;VAGINAL; 0.01%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ESTRACE | ESTRADIOL | 0.01% | CREAM;VAGINAL | Prescription | Yes | AB | 086069 | ALLERGAN |
| ESTRADIOL | ESTRADIOL | 0.01% | CREAM;VAGINAL | Prescription | No | AB | 209767 | ENCUBE |
| ESTRADIOL | ESTRADIOL | 0.01% | CREAM;VAGINAL | Prescription | No | AB | 208788 | MYLAN |
| ESTRADIOL | ESTRADIOL | 0.01% | CREAM;VAGINAL | Prescription | No | AB | 210194 | PADAGIS ISRAEL |
| ESTRADIOL | ESTRADIOL | 0.01% | CREAM;VAGINAL | Prescription | No | AB | 212313 | PRASCO |
| ESTRADIOL | ESTRADIOL | 0.01% | CREAM;VAGINAL | Prescription | No | AB | 210488 | TEVA PHARMS USA |