Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050782
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAGEL | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | AB2 | Yes | 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 |
---|---|---|---|---|---|---|---|
11/27/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50782lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50782LTR-LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-782_Clindagel.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/27/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50782lbl.pdf |
CLINDAGEL
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 |