Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207323
Company: GLAND PHARMA LTD
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
03/17/2017 ORIG-1 Approval STANDARD

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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