Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078548
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IMIQUIMOD | IMIQUIMOD | 5% | 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 |
---|---|---|---|---|---|---|---|
02/25/2010 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078548s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078548Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/18/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
09/18/2015 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Package Insert |
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 |