Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065184
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
CLEOCIN T CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription Yes AT 050537 PHARMACIA AND UPJOHN
CLINDA-DERM CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 063329 PADDOCK LLC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 208767 CADILA
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 065254 FOUGERA PHARMS
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 062811 G AND W LABS INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 209846 GLASSHOUSE PHARMS
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 064050 PERRIGO NEW YORK
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 206945 TELIGENT PHARMA INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 203343 VINTAGE PHARMS

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