Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020793
Company: HIKMA
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) SOLUTION;ORAL Prescription AA Yes Yes
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.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 205013 AUROBINDO PHARMA LTD
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 077906 LUITPOLD
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
CAFFEINE CITRATE CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 090077 SUN PHARM

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
CAFCIT CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION;ORAL Prescription Yes AA 020793 HIKMA
CAFFEINE CITRATE CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION;ORAL Prescription No AA 077304 EXELA PHARMA SCS LLC
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 091102 SAGENT PHARMS
CAFFEINE CITRATE CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) SOLUTION;ORAL Prescription No AA 090357 SUN PHARM

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