Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211229
Company: AMNEAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARMUSTINE CARMUSTINE 100MG/VIAL 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
10/16/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

CARMUSTINE

INJECTABLE;INJECTION; 100MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BICNU CARMUSTINE 100MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 017422 EMCURE PHARMS LTD
CARMUSTINE CARMUSTINE 100MG/VIAL INJECTABLE;INJECTION Prescription No AP 211229 AMNEAL
CARMUSTINE CARMUSTINE 100MG/VIAL INJECTABLE;INJECTION Prescription No AP 210179 NAVINTA LLC
CARMUSTINE CARMUSTINE 100MG/VIAL INJECTABLE;INJECTION Prescription No AP 209278 STI PHARMA LLC

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