Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211783
Company: CHEMO RESEARCH SL
Company: CHEMO RESEARCH SL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.1% | GEL;TRANSDERMAL | 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 |
---|---|---|---|---|---|---|---|
08/10/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211783orig1s000ltr.pdf |
ESTRADIOL
GEL;TRANSDERMAL; 0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIVIGEL | ESTRADIOL | 0.1% | GEL;TRANSDERMAL | Prescription | Yes | AB | 022038 | VERTICAL PHARMS |
ESTRADIOL | ESTRADIOL | 0.1% | GEL;TRANSDERMAL | Prescription | No | AB | 211783 | CHEMO RESEARCH SL |
ESTRADIOL | ESTRADIOL | 0.1% | GEL;TRANSDERMAL | Prescription | No | AB | 217610 | NOVITIUM PHARMA |
ESTRADIOL | ESTRADIOL | 0.1% | GEL;TRANSDERMAL | Prescription | No | AB | 216524 | PADAGIS ISRAEL |