An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090109
Company: SAGENT PHARMS INC

Products on ANDA 090109

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090109

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/2011	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
02/09/2021	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
02/09/2021	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
02/09/2021	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/16/2018	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/16/2018	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
04/16/2018	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/16/2018	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/27/2011	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 090109

CLINDAMYCIN PHOSPHATE

INJECTABLE;INJECTION; EQ 150MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLEOCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	050441	PFIZER
CLEOCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	062803	PFIZER
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	062800	ALMAJECT
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	062943	ALMAJECT
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	065346	FRESENIUS KABI USA
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	065347	FRESENIUS KABI USA
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	062889	HIKMA
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	065206	HIKMA
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	090108	SAGENT PHARMS INC
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 150MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	090109	SAGENT PHARMS INC

Top