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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208084
Company: BAXTER HLTHCARE CORP

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
06/28/2017 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2023 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
09/18/2023 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
05/14/2020 SUPPL-2 Labeling-Container/Carton Labels, 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 208084 BAXTER HLTHCARE CORP
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203048 RISING
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE;INJECTION Prescription No AP 201692 SANDOZ INC
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE;INJECTION Prescription No AP 214401 HIKMA

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 208084 BAXTER HLTHCARE CORP
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203048 RISING
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE;INJECTION Prescription No AP 201692 SANDOZ INC
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE;INJECTION Prescription No AP 214401 HIKMA

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 208084 BAXTER HLTHCARE CORP
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203048 RISING
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML INJECTABLE;INJECTION Prescription No AP 201692 SANDOZ INC
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML INJECTABLE;INJECTION Prescription No AP 214401 HIKMA
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