Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074656
Company: PHARMACHEMIE BV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CISPLATIN CISPLATIN 1MG/ML INJECTABLE;INJECTION 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
05/16/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74656ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/22/2015 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

03/15/2012 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

01/23/2012 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

10/17/2008 SUPPL-6 Labeling

Label is not available on this site.

07/01/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/2002 SUPPL-1 Manufacturing (CMC)-Control

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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