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Abbreviated New Drug Application (ANDA): 064159
Company: FOUGERA PHARMS INC
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
06/05/1997 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/064159.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/02/2005 SUPPL-4 Labeling

Label is not available on this site.

06/16/2004 SUPPL-2 Labeling

Label is not available on this site.

02/26/2001 SUPPL-1 Manufacturing (CMC)

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 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 064159 FOUGERA PHARMS 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 PADAGIS US
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 206945 PAI HOLDINGS PHARM
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 065184 TARO PHARM INDS
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