Details for New Drug Application (NDA): 077100
✉ 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 077100
Tradename: | DIVALPROEX SODIUM |
Applicant: | Zydus Pharms Usa Inc |
Ingredient: | divalproex sodium |
Patents: | 0 |
Pharmacology for NDA: 077100
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 077100
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 077100 | ANDA | Zydus Lifesciences Limited | 65841-634 | 65841-634-01 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (65841-634-01) |
DIVALPROEX SODIUM | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 077100 | ANDA | Zydus Lifesciences Limited | 65841-634 | 65841-634-05 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (65841-634-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 125MG VALPROIC ACID | ||||
Approval Date: | Mar 5, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 250MG VALPROIC ACID | ||||
Approval Date: | Mar 5, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 500MG VALPROIC ACID | ||||
Approval Date: | Mar 5, 2009 | TE: | AB | RLD: | No |
Complete Access Available with Subscription