Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 020167
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESTRADIOL | ESTRADIOL | 0.025MG/DAY | SYSTEM; TRANSDERMAL | Prescription | None | TBD | No |
| ESTRADIOL | ESTRADIOL | 0.0375MG/DAY | SYSTEM; TRANSDERMAL | Prescription | None | TBD | No |
| ESTRADIOL | ESTRADIOL | 0.05MG/DAY | SYSTEM; TRANSDERMAL | Prescription | None | TBD | No |
| ESTRADIOL | ESTRADIOL | 0.075MG/DAY | SYSTEM; TRANSDERMAL | Prescription | None | TBD | No |
| ESTRADIOL | ESTRADIOL | 0.1MG/DAY | SYSTEM; TRANSDERMAL | Prescription | None | TBD | 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 |
|---|---|---|---|---|---|---|---|
| 12/19/2014 | ORIG-1 | Approval | UNKNOWN |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/0201675Orig1s000.pdf |