Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078522
Company: FRESENIUS KABI USA

Products on ANDA 078522

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078522

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/2007	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
05/18/2022	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
02/14/2013	SUPPL-2	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 078522

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

Therapeutic Equivalents for ANDA 078522

GRANISETRON HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 0.1MG BASE/ML (EQ 0.1MG 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 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078262	AMNEAL
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078863	BIONPHARMA
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078392	DR REDDYS
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078522	FRESENIUS KABI USA
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	077913	HIKMA
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091136	MYLAN ASI
GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078534	SANDOZ