Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077304
Company: EXELA PHARMA

Products on ANDA 077304

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077304

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077304s000ltr.pdf

Therapeutic Equivalents for ANDA 077304

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