Details for New Drug Application (NDA): 018723
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NDA 018723 describes DEPAKOTE, which is a drug marketed by Abbvie and Abbott and is included in four NDAs. It is available from two suppliers. Additional details are available on the DEPAKOTE profile page.
The generic ingredient in DEPAKOTE 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.
The generic ingredient in DEPAKOTE 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 018723
| Tradename: | DEPAKOTE |
| Applicant: | Abbvie |
| Ingredient: | divalproex sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018723
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 018723
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723 | NDA | AbbVie Inc. | 0074-7325 | 0074-7325-13 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-7325-13) |
| DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723 | NDA | AbbVie Inc. | 0074-7326 | 0074-7326-13 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-7326-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 250MG VALPROIC ACID | ||||
| Approval Date: | Mar 10, 1983 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 500MG VALPROIC ACID | ||||
| Approval Date: | Mar 10, 1983 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 125MG VALPROIC ACID | ||||
| Approval Date: | Oct 26, 1984 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 018723
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723-001 | Mar 10, 1983 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723-001 | Mar 10, 1983 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723-002 | Mar 10, 1983 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723-003 | Oct 26, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723-002 | Mar 10, 1983 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723-003 | Oct 26, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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