Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206958
Company: ORIT LABS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINDAMYCIN PALMITATE HYDROCHLORIDE CLINDAMYCIN PALMITATE HYDROCHLORIDE EQ 75MG BASE/5ML FOR SOLUTION;ORAL Prescription AA 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
05/05/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

CLINDAMYCIN PALMITATE HYDROCHLORIDE

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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