Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065049
Company: PADAGIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB;TOPICAL Prescription AT No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/25/2000 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65049ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/065049_clindamycin_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/03/2020 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

04/03/2020 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

07/15/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

01/14/2014 SUPPL-11 Labeling-Container/Carton Labels

Label is not available on this site.

10/19/2010 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

11/30/2009 SUPPL-9 Labeling

Label is not available on this site.

06/27/2002 SUPPL-5 Labeling

Label is not available on this site.

06/27/2002 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/21/2001 SUPPL-3 Labeling

Label is not available on this site.

11/21/2001 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

11/21/2001 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

CLINDAMYCIN PHOSPHATE

SWAB;TOPICAL; EQ 1% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB;TOPICAL Prescription No AT 065513 AKORN
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB;TOPICAL Prescription No AT 065049 PADAGIS US
CLINDETS CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB;TOPICAL Prescription No AT 064136 PADAGIS US

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