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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090827
Company: SAGENT PHARMS

Products on ANDA 090827

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAFFEINE CITRATE	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090827

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2012	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
01/02/2017	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
02/25/2013	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090827

CAFFEINE CITRATE

SOLUTION;INTRAVENOUS; EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CAFCIT	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	020793	HIKMA
CAFFEINE CITRATE	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	077906	AM REGENT
CAFFEINE CITRATE	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	205013	EUGIA PHARMA
CAFFEINE CITRATE	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	077233	EXELA PHARMA SCIENCE
CAFFEINE CITRATE	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	077997	FRESENIUS KABI USA
CAFFEINE CITRATE	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207400	MICRO LABS
CAFFEINE CITRATE	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	090827	SAGENT PHARMS

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