Details for New Drug Application (NDA): 077100
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The generic ingredient in DIVALPROEX SODIUM is divalproex sodium. There are eighteen drug master file entries for this compound. Forty-one 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 |
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