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CAFFEINE CITRATE از شرکت SAGENT PHARMS

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CAFFEINE CITRATE از شرکت SAGENT PHARMS

Abbreviated New Drug Application (ANDA): 090827

Company: SAGENT PHARMS

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
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.

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 PHARMS
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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