Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062644
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLEOCIN CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION;ORAL Prescription AA 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
04/07/1986 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/22/2019 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

10/22/2019 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

08/16/2017 SUPPL-27 Labeling

Label is not available on this site.

11/07/2016 SUPPL-25 Labeling

Label is not available on this site.

11/07/2016 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

09/25/2014 SUPPL-22 Labeling

Label is not available on this site.

09/25/2014 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

11/07/2016 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

11/21/2007 SUPPL-15 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/062644s015lbl.pdf
12/11/2014 SUPPL-9 Labeling

Label is not available on this site.

09/29/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/21/2007 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/062644s015lbl.pdf

CLEOCIN

FOR SOLUTION;ORAL; EQ 75MG BASE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLEOCIN CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION;ORAL Prescription No AA 062644 PHARMACIA AND UPJOHN
CLINDAMYCIN PALMITATE HYDROCHLORIDE CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION;ORAL Prescription No AA 203513 AMNEAL PHARMS
CLINDAMYCIN PALMITATE HYDROCHLORIDE CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION;ORAL Prescription No AA 202409 AUROBINDO PHARMA LTD
CLINDAMYCIN PALMITATE HYDROCHLORIDE CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION;ORAL Prescription No AA 207047 HERITAGE PHARMS INC
CLINDAMYCIN PALMITATE HYDROCHLORIDE CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION;ORAL Prescription No AA 201821 LYNE
CLINDAMYCIN PALMITATE HYDROCHLORIDE CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION;ORAL Prescription No AA 206958 ORIT LABS LLC
CLINDAMYCIN PALMITATE HYDROCHLORIDE CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION;ORAL Prescription No AA 090902 PADDOCK LLC

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