Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207323
Company: GLAND PHARMA LTD

Products on ANDA 207323

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 207323

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207323

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