Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078002
Company: FRESENIUS KABI USA

Products on ANDA 078002

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;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078002

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2008	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 078002

CAFFEINE CITRATE

SOLUTION;ORAL; EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CAFFEINE CITRATE	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION;ORAL	Prescription	No	AA	077304	EXELA PHARMA
CAFFEINE CITRATE	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION;ORAL	Prescription	No	AA	078002	FRESENIUS KABI USA
CAFFEINE CITRATE	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION;ORAL	Prescription	No	AA	213202	MICRO LABS
CAFFEINE CITRATE	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION;ORAL	Prescription	No	AA	091102	SAGENT PHARMS
CAFFEINE CITRATE	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION;ORAL	Prescription	No	AA	090357	SUN PHARM