Details for New Drug Application (NDA): 021168
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NDA 021168 describes DEPAKOTE ER, which is a drug marketed by Abbvie and is included in one NDA. It is available from two suppliers. Additional details are available on the DEPAKOTE ER profile page.
The generic ingredient in DEPAKOTE ER 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 ER 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 021168
| Tradename: | DEPAKOTE ER |
| Applicant: | Abbvie |
| Ingredient: | divalproex sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021168
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 021168
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168 | NDA | AbbVie Inc. | 0074-3826 | 0074-3826-13 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-3826-13) |
| DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168 | NDA | AbbVie Inc. | 0074-7401 | 0074-7401-13 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-7401-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 500MG VALPROIC ACID | ||||
| Approval Date: | Aug 4, 2000 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 250MG VALPROIC ACID | ||||
| Approval Date: | May 31, 2002 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021168
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-002 | May 31, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-002 | May 31, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-002 | May 31, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-002 | May 31, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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