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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075036
Company: HIKMA

Products on ANDA 075036

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CISPLATIN	CISPLATIN	1MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075036

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/2000/75036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75036ta.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.

Labels for ANDA 075036

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

Therapeutic Equivalents for ANDA 075036

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	No	AP	075036	HIKMA
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	218868	QILU

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