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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077059
Company: HOSPIRA

Products on ANDA 077059

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077059

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/23/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077059ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2017	SUPPL-19	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/07/2005	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077059

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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