Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211027
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HALCINONIDE | HALCINONIDE | 0.1% | CREAM;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
08/12/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211027Orig1s000ltr.pdf |
HALCINONIDE
CREAM;TOPICAL; 0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HALCINONIDE | HALCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 214723 | CHARTWELL RX |
HALCINONIDE | HALCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 211027 | MYLAN |
HALOG | HALCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | Yes | AB | 017556 | SUN PHARM INDS INC |