U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077266
Company: FRESENIUS KABI USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Discontinued None No No
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Discontinued None 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
02/15/2006 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
04/09/2020 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

CARBOPLATIN

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
Back to Top