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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201692
Company: SANDOZ INC

Products on ANDA 201692

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201692

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/2012	ORIG-1	Approval	Not Applicable		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201692Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2022	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
10/18/2022	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
10/18/2022	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
05/18/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
05/18/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
05/18/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
05/18/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/18/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
05/18/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201692

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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