Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202543
Company: HQ SPECIALITY PHARMA
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 Yes Yes
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1000MG/100ML (10MG/ML) INJECTABLE;IV (INFUSION) Prescription AP Yes Yes
LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM 1500MG/100ML (15MG/ML) INJECTABLE;IV (INFUSION) Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/09/2011 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202543lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202543s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202543_levetiracetam_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202543Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/12/2017 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202543s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202543Orig1s010ltr.pdf
11/18/2016 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202543s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202543Orig1s008,s009ltr.pdf
11/18/2016 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202543s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202543Orig1s008,s009ltr.pdf
07/14/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/03/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/04/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/07/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/09/2012 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/12/2017 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202543s010lbl.pdf
11/18/2016 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202543s008s009lbl.pdf
11/18/2016 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202543s008s009lbl.pdf
11/09/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202543lbl.pdf

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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