Drugs@FDA: FDA Approved Drug Products

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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;IV (INFUSION) Prescription AP No No
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1000MG/100ML (10MG/ML) INJECTABLE;IV (INFUSION) Prescription AP No No
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1500MG/100ML (15MG/ML) INJECTABLE;IV (INFUSION) 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.

LEVETIRACETAM IN SODIUM CHLORIDE

INJECTABLE;IV (INFUSION); 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;IV (INFUSION) Prescription No AP 207160 AUROBINDO PHARMA LTD
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 500MG/100ML (5MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 206880 GLAND PHARMA LTD
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 500MG/100ML (5MG/ML) INJECTABLE;IV (INFUSION) Prescription Yes AP 202543 HQ SPECIALITY PHARMA

INJECTABLE;IV (INFUSION); 1000MG/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 1000MG/100ML (10MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 207160 AUROBINDO PHARMA LTD
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1000MG/100ML (10MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 206880 GLAND PHARMA LTD
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1000MG/100ML (10MG/ML) INJECTABLE;IV (INFUSION) Prescription Yes AP 202543 HQ SPECIALITY PHARMA

INJECTABLE;IV (INFUSION); 1500MG/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 1500MG/100ML (15MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 207160 AUROBINDO PHARMA LTD
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1500MG/100ML (15MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 206880 GLAND PHARMA LTD
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1500MG/100ML (15MG/ML) INJECTABLE;IV (INFUSION) Prescription Yes AP 202543 HQ SPECIALITY PHARMA

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