Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064160
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL;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
01/28/2000 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/64160ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/064160_Clindamycin_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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.

03/31/2003 SUPPL-5 Labeling

Label is not available on this site.

12/16/2002 SUPPL-2 Labeling

Label is not available on this site.

07/27/2001 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CLINDAMYCIN PHOSPHATE

GEL;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 GEL;TOPICAL Prescription Yes AB 050615 PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL;TOPICAL Prescription No AB 064160 FOUGERA PHARMS

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