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CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER از شرکت AKORN

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داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER از شرکت AKORN

Abbreviated New Drug Application (ANDA): 203048

Company: AKORN


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.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/14/2020 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
05/14/2020 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
05/14/2020 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
05/14/2020 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
05/14/2020 SUPPL-1 Labeling-Package Insert

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
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203048 AKORN
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
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203048 AKORN
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
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203048 AKORN
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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