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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020793
Company: HIKMA

Products on NDA 020793

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAFCIT	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
CAFCIT	CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020793

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/1999	ORIG-1	Approval	Type 2 - New Active Ingredient	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20793lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20793ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020793_000_CafcitTOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/02/2020	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020793s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020793Orig1s019ltr.pdf
12/23/2014	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/11/2010	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020793s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020793s009ltr.pdf
03/08/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/08/2002	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20793s4ltr.pdf
01/18/2002	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20793s3ltr.pdf
04/14/2000	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/12/2000	SUPPL-1	Efficacy-New Route Of Administration	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20793s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20793s1ltr.pdf

Labels for NDA 020793

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/02/2020	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020793s019lbl.pdf
06/11/2010	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020793s009lbl.pdf
04/12/2000	SUPPL-1	Efficacy-New Route Of Administration	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20793s1lbl.pdf
09/21/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20793lbl.pdf

Therapeutic Equivalents for NDA 020793

CAFCIT

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	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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