Details for New Drug Application (NDA): 206880
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The generic ingredient in LEVETIRACETAM IN SODIUM CHLORIDE is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 206880
Tradename: | LEVETIRACETAM IN SODIUM CHLORIDE |
Applicant: | Gland Pharma Ltd |
Ingredient: | levetiracetam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206880
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 206880
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 206880 | ANDA | Dr.Reddy's Laboratories Inc | 43598-635 | 43598-635-10 | 10 BAG in 1 CARTON (43598-635-10) / 100 mL in 1 BAG (43598-635-52) |
LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 206880 | ANDA | Dr.Reddy's Laboratories Inc | 43598-636 | 43598-636-10 | 10 BAG in 1 CARTON (43598-636-10) / 100 mL in 1 BAG (43598-636-52) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 500MG/100ML (5MG/ML) | ||||
Approval Date: | Oct 25, 2017 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 1GM/100ML (10MG/ML) | ||||
Approval Date: | Oct 25, 2017 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 1.5GM/100ML (15MG/ML) | ||||
Approval Date: | Oct 25, 2017 | TE: | AP | RLD: | No |
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