Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214668
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | AB2 | 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 |
---|---|---|---|---|---|---|---|
08/05/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214668Orig1s000ltr.pdf |
CLINDAMYCIN PHOSPHATE
GEL;TOPICAL; EQ 1% BASE
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLINDAGEL | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | Yes | AB2 | 050782 | BAUSCH |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB2 | 214668 | AMNEAL |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB2 | 212842 | SOLARIS PHARMA CORP |