Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076387
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOTRIMAZOLE | CLOTRIMAZOLE | 10MG | TROCHE/LOZENGE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/29/2004 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76387ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076387_Clotrimazole LozengesTOC.cfm |
CLOTRIMAZOLE
TROCHE/LOZENGE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOTRIMAZOLE | CLOTRIMAZOLE | 10MG | TROCHE/LOZENGE;ORAL | Prescription | No | AB | 076387 | HIKMA |
CLOTRIMAZOLE | CLOTRIMAZOLE | 10MG | TROCHE/LOZENGE;ORAL | Prescription | No | AB | 076763 | PADAGIS US |
CLOTRIMAZOLE | CLOTRIMAZOLE | 10MG | TROCHE/LOZENGE;ORAL | Prescription | No | AB | 215641 | THINQ PHARM-CRO PVT |