Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077269
Company: PHARMACHEMIE BV
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 Yes
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription AP No Yes
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription AP No Yes
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription AP No 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
10/14/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77269ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/26/2012 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/28/2007 SUPPL-2 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 AKORN
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077861 CIPLA LTD
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 077096 HONG KONG
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 INGENUS PHARMS LLC
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 078631 PLIVA LACHEMA
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078280 SANDOZ INC
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 077139 TEVA PHARMS USA
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077244 WEST-WARD PHARMS INT

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 AKORN
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077861 CIPLA LTD
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 077096 HONG KONG
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 INGENUS PHARMS LLC
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 078631 PLIVA LACHEMA
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078280 SANDOZ INC
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 077139 TEVA PHARMS USA
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077244 WEST-WARD PHARMS INT

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 AKORN
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077861 CIPLA LTD
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 077096 HONG KONG
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 INGENUS PHARMS LLC
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 078631 PLIVA LACHEMA
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078280 SANDOZ INC
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 077139 TEVA PHARMS USA
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077244 WEST-WARD PHARMS INT

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 AKORN
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077861 CIPLA LTD
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 077096 HONG KONG
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 INGENUS PHARMS LLC
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 078631 PLIVA LACHEMA
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077139 TEVA PHARMS USA
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 077244 WEST-WARD PHARMS INT

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