Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063329
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINDA-DERM | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 09/30/1992 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/05/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/14/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLINDA-DERM
SOLUTION;TOPICAL; EQ 1% BASE
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLINDA-DERM | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 063329 | PADAGIS US |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 209846 | CHARTWELL RX |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 209914 | ENCUBE ETHICALS |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 064159 | FOUGERA PHARMS INC |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 064050 | PADAGIS US |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 065184 | TARO PHARM INDS |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 208767 | ZYDUS LIFESCIENCES |