Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202985
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.025MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
ESTRADIOL | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
ESTRADIOL | ESTRADIOL | 0.06MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
ESTRADIOL | ESTRADIOL | 0.075MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
ESTRADIOL | ESTRADIOL | 0.1MG/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 |
---|---|---|---|---|---|---|---|
03/29/2023 | ORIG-1 | Approval |
Label is not available on this site. |