Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050803
Company: ALMIRALL
Company: ALMIRALL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VELTIN | CLINDAMYCIN PHOSPHATE; TRETINOIN | 1.2%;0.025% | 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 |
---|---|---|---|---|---|---|---|
07/16/2010 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050803s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050803s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050803s000_veltin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050803Orig1s000SumR.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/16/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050803s000lbl.pdf |
VELTIN
GEL;TOPICAL; 1.2%;0.025%
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE AND TRETINOIN | CLINDAMYCIN PHOSPHATE; TRETINOIN | 1.2%;0.025% | GEL;TOPICAL | Prescription | No | AB2 | 216943 | ENCUBE |
CLINDAMYCIN PHOSPHATE AND TRETINOIN | CLINDAMYCIN PHOSPHATE; TRETINOIN | 1.2%;0.025% | GEL;TOPICAL | Prescription | No | AB2 | 212845 | SOLARIS PHARMA CORP |
VELTIN | CLINDAMYCIN PHOSPHATE; TRETINOIN | 1.2%;0.025% | GEL;TOPICAL | Prescription | Yes | AB2 | 050803 | ALMIRALL |