Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209815
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | SOLUTION;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
02/15/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CLOTRIMAZOLE
SOLUTION;TOPICAL; 1%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | SOLUTION;TOPICAL | Prescription | No | AT | 209815 | NOVITIUM PHARMA |
CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | SOLUTION;TOPICAL | Prescription | No | AT | 216569 | SCIEGEN PHARMS INC |
CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | SOLUTION;TOPICAL | Prescription | No | AT | 074580 | TARO |
CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | SOLUTION;TOPICAL | Prescription | No | AT | 212281 | TASMAN PHARMA |
CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | SOLUTION;TOPICAL | Prescription | No | AT | 073306 | TEVA |