Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203048
Company: AKORN INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE;INJECTION Prescription AP No No
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE;INJECTION Prescription AP No No
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML INJECTABLE;INJECTION Prescription AP 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
04/04/2013 ORIG-1 Approval

Label is not available on this site.

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER

INJECTABLE;INJECTION; EQ 6MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 050639 PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203048 AKORN INC
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE;INJECTION Prescription No AP 208084 BAXTER HLTHCARE CORP
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE;INJECTION Prescription No AP 201692 SANDOZ INC

INJECTABLE;INJECTION; EQ 12MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 050639 PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203048 AKORN INC
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE;INJECTION Prescription No AP 208084 BAXTER HLTHCARE CORP
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE;INJECTION Prescription No AP 201692 SANDOZ INC

INJECTABLE;INJECTION; EQ 18MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 050639 PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203048 AKORN INC
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML INJECTABLE;INJECTION Prescription No AP 208084 BAXTER HLTHCARE CORP
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML INJECTABLE;INJECTION Prescription No AP 201692 SANDOZ INC

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