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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204312
Company: EUGIA PHARMA

Products on ANDA 204312

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204312

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/01/2016	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204312Origs000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204312Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
04/20/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/20/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/20/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/20/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 204312

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/01/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204312Origs000lbl.pdf

Therapeutic Equivalents for ANDA 204312

LEVETIRACETAM

INJECTABLE;INTRAVENOUS; 500MG/5ML (100MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KEPPRA	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	021872	UCB INC
LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	091485	ADRASTEA PHARMA
LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204312	EUGIA PHARMA
LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	090876	FRESENIUS KABI USA
LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	209781	HAINAN POLY PHARM
LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	090981	HIKMA FARMACEUTICA
LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202869	HOSPIRA INC
LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	211954	MICRO LABS
LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215980	MSN
LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203308	MYLAN LABS LTD
LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	209474	PRINSTON INC
LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	091627	SAGENT PHARMS
LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	090754	SUN PHARM INDS LTD

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