Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065067
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | LOTION;TOPICAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 01/31/2002 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065067.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/22/2025 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2025 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2025 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2025 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2025 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/02/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/16/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/13/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 12/16/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE
LOTION;TOPICAL; EQ 1% BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLEOCIN T | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | LOTION;TOPICAL | Prescription | Yes | AB | 050600 | PFIZER |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | LOTION;TOPICAL | Prescription | No | AB | 215607 | ENCUBE |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | LOTION;TOPICAL | Prescription | No | AB | 065067 | FOUGERA PHARMS |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | LOTION;TOPICAL | Prescription | No | AB | 214604 | PADAGIS ISRAEL |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | LOTION;TOPICAL | Prescription | No | AB | 214526 | SUN PHARMA CANADA |