Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090785
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | 1% | AEROSOL, FOAM;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
03/31/2010 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090785s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090785Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/05/2024 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2012 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE
AEROSOL, FOAM;TOPICAL; 1%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | 1% | AEROSOL, FOAM;TOPICAL | Prescription | No | AT | 210778 | GLENMARK PHARMS LTD |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | 1% | AEROSOL, FOAM;TOPICAL | Prescription | No | AT | 090785 | PADAGIS ISRAEL |
CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | 1% | AEROSOL, FOAM;TOPICAL | Prescription | No | AT | 210004 | TARO |