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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206880
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 500MG/100ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription AP No No
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1GM/100ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription AP No No
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1.5GM/100ML (15MG/ML) INJECTABLE;INTRAVENOUS 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
10/25/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/20/2020 SUPPL-5 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.

LEVETIRACETAM IN SODIUM CHLORIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 500MG/100ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207160 EUGIA PHARMA
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 500MG/100ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 206880 GLAND PHARMA LTD
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 500MG/100ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 202543 HQ SPECIALITY PHARMA
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 500MG/100ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 213532 NEXUS PHARMS

INJECTABLE;INTRAVENOUS; 1GM/100ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1GM/100ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207160 EUGIA PHARMA
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1GM/100ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 206880 GLAND PHARMA LTD
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1GM/100ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 202543 HQ SPECIALITY PHARMA
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1GM/100ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 213532 NEXUS PHARMS

INJECTABLE;INTRAVENOUS; 1.5GM/100ML (15MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1.5GM/100ML (15MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207160 EUGIA PHARMA
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1.5GM/100ML (15MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 206880 GLAND PHARMA LTD
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1.5GM/100ML (15MG/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 202543 HQ SPECIALITY PHARMA
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1.5GM/100ML (15MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 213532 NEXUS PHARMS
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