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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077244
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription AP No No
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription AP No No
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription AP No No
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;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
10/15/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77244ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/13/2012 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
09/07/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
01/20/2006 SUPPL-3 Labeling

Label is not available on this site.
01/20/2006 SUPPL-2 Manufacturing (CMC)-New Strength

Label is not available on this site.
07/11/2005 SUPPL-1 Labeling

Label is not available on this site.

CARBOPLATIN

INJECTABLE;INTRAVENOUS; 50MG/5ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 206775 ACCORD HLTHCARE
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 090475 EPIC PHARMA LLC
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 205487 EUGIA PHARMA
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207324 GLAND PHARMA LTD
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077244 HIKMA
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 076517 HOSPIRA
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 208487 NOVAST LABS
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077269 PHARMACHEMIE BV
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078280 SANDOZ
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077926 SUN PHARM
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077861 TEYRO LABS

INJECTABLE;INTRAVENOUS; 150MG/15ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 206775 ACCORD HLTHCARE
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 090475 EPIC PHARMA LLC
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 205487 EUGIA PHARMA
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207324 GLAND PHARMA LTD
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077244 HIKMA
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 076517 HOSPIRA
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 208487 NOVAST LABS
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077269 PHARMACHEMIE BV
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078280 SANDOZ
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077926 SUN PHARM
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077861 TEYRO LABS

INJECTABLE;INTRAVENOUS; 450MG/45ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 206775 ACCORD HLTHCARE
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 090475 EPIC PHARMA LLC
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 205487 EUGIA PHARMA
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077247 FRESENIUS KABI USA
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077266 FRESENIUS KABI USA
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207324 GLAND PHARMA LTD
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077244 HIKMA
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 076517 HOSPIRA
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 208487 NOVAST LABS
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077269 PHARMACHEMIE BV
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078280 SANDOZ
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077926 SUN PHARM
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077861 TEYRO LABS

INJECTABLE;INTRAVENOUS; 600MG/60ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 206775 ACCORD HLTHCARE
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 091268 EPIC PHARMA LLC
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 205487 EUGIA PHARMA
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077266 FRESENIUS KABI USA
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207324 GLAND PHARMA LTD
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077244 HIKMA
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077059 HOSPIRA
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 208487 NOVAST LABS
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077269 PHARMACHEMIE BV
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077861 TEYRO LABS
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