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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091268
Company: EPIC PHARMA LLC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
07/28/2010 ORIG-1 Approval

Label is not available on this site.

CARBOPLATIN

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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