Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021167
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VIVELLE | ESTRADIOL | 0.0375MG/24HR | FILM, EXTENDED RELEASE; TRANSDERMAL | Discontinued | None | No | No |
VIVELLE | ESTRADIOL | 0.05MG/24HR | FILM, EXTENDED RELEASE; TRANSDERMAL | Prescription | None | No | No |
VIVELLE | ESTRADIOL | 0.075MG/24HR | FILM, EXTENDED RELEASE; TRANSDERMAL | Discontinued | None | No | No |
VIVELLE | ESTRADIOL | 0.1MG/24HR | FILM, EXTENDED RELEASE; TRANSDERMAL | Prescription | None | No | No |
VIVELLE | 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 |
---|---|---|---|---|---|---|---|
08/16/2000 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20323S23ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-167_20-323S23_Vivelle.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/16/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf |