Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210778
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 09/20/2021 | ORIG-1 | Approval | STANDARD |
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 |