Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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 1000MG/100ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription AP No No
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1500MG/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 AUROBINDO PHARMA LTD
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; 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;INTRAVENOUS Prescription No AP 207160 AUROBINDO PHARMA LTD
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1000MG/100ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 206880 GLAND PHARMA LTD
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1000MG/100ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 202543 HQ SPECIALITY PHARMA
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1000MG/100ML (10MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 213532 NEXUS PHARMS

INJECTABLE;INTRAVENOUS; 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;INTRAVENOUS Prescription No AP 207160 AUROBINDO PHARMA LTD
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1500MG/100ML (15MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 206880 GLAND PHARMA LTD
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1500MG/100ML (15MG/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 202543 HQ SPECIALITY PHARMA
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1500MG/100ML (15MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 213532 NEXUS PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English