Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018057
Company: HQ SPCLT PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CISPLATIN CISPLATIN 1MG/ML INJECTABLE;INJECTION Prescription AP Yes No
PLATINOL CISPLATIN 10MG/VIAL INJECTABLE;INJECTION Discontinued None Yes No
PLATINOL CISPLATIN 50MG/VIAL INJECTABLE;INJECTION Discontinued None Yes No
PLATINOL-AQ CISPLATIN 0.5MG/ML INJECTABLE;INJECTION Discontinued None Yes 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
12/19/1978 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/19/2017 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

10/06/2015 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

03/03/2015 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

02/26/2015 SUPPL-83 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018057s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018057Orig1s083ltr.pdf
02/06/2014 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

12/29/2011 SUPPL-81 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018057s081ltr.pdf
08/26/2011 SUPPL-80 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018057s080ltr.pdf
09/02/2010 SUPPL-79 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018057s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018057s079ltr.pdf
11/08/2002 SUPPL-76 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18057slr076ltr.pdf
01/16/2001 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

09/13/2000 SUPPL-74 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/05/1999 SUPPL-72 Labeling

Label is not available on this site.

04/18/1996 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

08/09/1995 SUPPL-65 Labeling

Label is not available on this site.

12/04/1995 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

12/13/1995 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

05/17/1993 SUPPL-62 Labeling

Label is not available on this site.

04/22/1993 SUPPL-61 Efficacy-New Dosing Regimen

Label is not available on this site.

03/25/1993 SUPPL-60 Labeling

Label is not available on this site.

11/01/1991 SUPPL-59 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/29/1990 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1991 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1992 SUPPL-56 Labeling

Label is not available on this site.

09/27/1990 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1991 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1990 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

12/11/1990 SUPPL-51 Labeling

Label is not available on this site.

01/12/1988 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1989 SUPPL-49 Labeling

Label is not available on this site.

11/08/1988 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/1987 SUPPL-46 Labeling

Label is not available on this site.

01/13/1988 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

05/05/1988 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

03/23/1987 SUPPL-43 Labeling

Label is not available on this site.

11/06/1986 SUPPL-42 Labeling

Label is not available on this site.

08/19/1986 SUPPL-41 Labeling

Label is not available on this site.

06/08/1987 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

08/26/1986 SUPPL-39 Labeling

Label is not available on this site.

01/22/1986 SUPPL-38 Labeling

Label is not available on this site.

03/05/1987 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/16/1985 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/03/1985 SUPPL-32 Labeling

Label is not available on this site.

03/05/1985 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/1985 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1988 SUPPL-27 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/31/1983 SUPPL-26 Labeling

Label is not available on this site.

04/04/1984 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1984 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1985 SUPPL-22 Labeling

Label is not available on this site.

05/02/1986 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1984 SUPPL-20 Labeling

Label is not available on this site.

01/13/1983 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/29/1981 SUPPL-12 Efficacy

Label is not available on this site.

03/12/1981 SUPPL-11 Labeling

Label is not available on this site.

07/04/1980 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/16/1980 SUPPL-9 Labeling

Label is not available on this site.

01/22/1981 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/26/1980 SUPPL-6 Labeling

Label is not available on this site.

01/31/1980 SUPPL-5 Labeling

Label is not available on this site.

01/31/1980 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/05/1979 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/18/1979 SUPPL-2 Labeling

Label is not available on this site.

09/11/1979 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/26/2015 SUPPL-83 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018057s083lbl.pdf
12/29/2011 SUPPL-81 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s081lbl.pdf
08/26/2011 SUPPL-80 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s080lbl.pdf
09/02/2010 SUPPL-79 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018057s079lbl.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 091062 MYLAN LABS LTD
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

PLATINOL

There are no Therapeutic Equivalents.

PLATINOL-AQ

There are no Therapeutic Equivalents.

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