Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065184
Company: TARO PHARM INDS
Company: TARO PHARM INDS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE | 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 |
---|---|---|---|---|---|---|---|
03/31/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065184_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/16/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
09/01/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
09/01/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE
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 |