Details for New Drug Application (NDA): 209286
✉ Email this page to a colleague
The generic ingredient in DIVALPROEX SODIUM is divalproex sodium. There are eighteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
Summary for 209286
Tradename: | DIVALPROEX SODIUM |
Applicant: | Lupin Ltd |
Ingredient: | divalproex sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209286
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 209286
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 209286 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8376 | 0615-8376-39 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8376-39) |
DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 209286 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8377 | 0615-8377-39 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8377-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 250MG VALPROIC ACID | ||||
Approval Date: | Oct 18, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 500MG VALPROIC ACID | ||||
Approval Date: | Oct 18, 2019 | TE: | AB | RLD: | No |
Complete Access Available with Subscription