Details for New Drug Application (NDA): 021168
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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. | 0074-7401 | 0074-7401-13 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-7401-13) |
DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168 | NDA | AbbVie Inc. | 0074-7402 | 0074-7402-13 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-7402-13) |
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 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-002 | May 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-002 | May 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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