Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203048
Company: RISING

Products on ANDA 203048

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203048

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.

Therapeutic Equivalents for ANDA 203048

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