Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078090
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/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
06/30/2008 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/19/2022 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

09/18/2014 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/078096Orig1s005,078090Orig1s005,078522Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078096Orig1s005,078090Orig1s005,078522Orig1s005ltr.pdf
02/15/2013 SUPPL-2 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/18/2014 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/078096Orig1s005,078090Orig1s005,078522Orig1s005lbl.pdf

GRANISETRON HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 079078 AKORN
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078880 BIONPHARMA INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077297 DR REDDYS
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 204238 EUGIA PHARMA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078090 FRESENIUS KABI USA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077177 HIKMA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077186 HIKMA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078629 HIKMA FARMACEUTICA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 091137 MYLAN ASI
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078258 PUNISKA
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078531 SANDOZ INC
GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078835 SANDOZ INC

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