Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074735
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CISPLATIN CISPLATIN 1MG/ML INJECTABLE;INJECTION 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
07/16/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74735ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/13/2012 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/08/2011 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/05/2002 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

02/22/2002 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/05/2001 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/16/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CISPLATIN

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CISPLATIN CISPLATIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 206774 ACCORD HLTHCARE
CISPLATIN CISPLATIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 074735 FRESENIUS KABI USA
CISPLATIN CISPLATIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 207323 GLAND PHARMA LTD
CISPLATIN CISPLATIN 1MG/ML INJECTABLE;INJECTION Prescription Yes AP 018057 HQ SPCLT PHARMA
CISPLATIN CISPLATIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 074656 PHARMACHEMIE BV
CISPLATIN CISPLATIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 075036 WEST-WARD PHARMS INT

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