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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207092
Company: GLAND

Products on ANDA 207092

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207092

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207092Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/05/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/05/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207092

CASPOFUNGIN ACETATE

POWDER;INTRAVENOUS; 50MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211263	AREVA PHARMS
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	206110	FRESENIUS KABI USA
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	207092	GLAND
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	216506	HANGZHOU ZHONGMEI
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	200833	HENGRUI PHARMA

POWDER;INTRAVENOUS; 70MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	211263	AREVA PHARMS
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	206110	FRESENIUS KABI USA
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	207092	GLAND
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	216506	HANGZHOU ZHONGMEI
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	200833	HENGRUI PHARMA

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