Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075036
Company: WEST-WARD PHARMS INT
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
11/07/2000 ORIG-1 Approval Label (PDF)
Letter (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-036_Cisplatin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75036ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-036_Cisplatin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/24/2018 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/15/2012 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/30/2012 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

03/08/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/21/2004 SUPPL-3 Labeling

Label is not available on this site.

06/21/2004 SUPPL-2

Label is not available on this site.

05/14/2001 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/07/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-036_Cisplatin_prntlbl.pdf

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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