Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211908
Company: GLAND PHARMA LTD

Products on ANDA 211908

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZIPRASIDONE MESYLATE	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER;INTRAMUSCULAR	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211908

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/26/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211908Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/08/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/02/2021	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
02/02/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211908

ZIPRASIDONE MESYLATE

POWDER;INTRAMUSCULAR; EQ 20MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GEODON	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER;INTRAMUSCULAR	Prescription	Yes	AP	020919	VIATRIS
ZIPRASIDONE MESYLATE	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER;INTRAMUSCULAR	Prescription	No	AP	211908	GLAND PHARMA LTD
ZIPRASIDONE MESYLATE	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER;INTRAMUSCULAR	Prescription	No	AP	216091	MSN