Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206388
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 10MCG | TABLET;VAGINAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
07/21/2017 | ORIG-1 | Approval | 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 |
---|---|---|---|---|---|
02/17/2021 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
02/17/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
ESTRADIOL
TABLET;VAGINAL; 10MCG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 10MCG | TABLET;VAGINAL | Prescription | No | AB | 205256 | AMNEAL PHARMS |
ESTRADIOL | ESTRADIOL | 10MCG | TABLET;VAGINAL | Prescription | No | AB | 210264 | GLENMARK PHARMS LTD |
ESTRADIOL | ESTRADIOL | 10MCG | TABLET;VAGINAL | Prescription | No | AB | 206388 | TEVA PHARMS USA |
VAGIFEM | ESTRADIOL | 10MCG | TABLET;VAGINAL | Prescription | Yes | AB | 020908 | NOVO NORDISK INC |