Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201994
Company: GLENMARK PHARMS INC
Company: GLENMARK PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IMIQUIMOD | IMIQUIMOD | 5% | CREAM;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
03/06/2012 | ORIG-1 | Approval |
Label is not available on this site. |
IMIQUIMOD
CREAM;TOPICAL; 5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IMIQUIMOD | IMIQUIMOD | 5% | CREAM;TOPICAL | Prescription | No | AB | 091308 | APOTEX INC |
IMIQUIMOD | IMIQUIMOD | 5% | CREAM;TOPICAL | Prescription | No | AB | 078548 | FOUGERA PHARMS |
IMIQUIMOD | IMIQUIMOD | 5% | CREAM;TOPICAL | Prescription | No | AB | 201994 | GLENMARK PHARMS INC |
IMIQUIMOD | IMIQUIMOD | 5% | CREAM;TOPICAL | Prescription | No | AB | 078837 | PADAGIS ISRAEL |
IMIQUIMOD | IMIQUIMOD | 5% | CREAM;TOPICAL | Prescription | No | AB | 200173 | TARO |