Details for New Drug Application (NDA): 075782
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The generic ingredient in VALPROIC ACID is valproic acid. There are seventeen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the valproic acid profile page.
Summary for 075782
Tradename: | VALPROIC ACID |
Applicant: | Chartwell Rx |
Ingredient: | valproic acid |
Patents: | 0 |
Pharmacology for NDA: 075782
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Medical Subject Heading (MeSH) Categories for 075782
Suppliers and Packaging for NDA: 075782
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VALPROIC ACID | valproic acid | SYRUP;ORAL | 075782 | ANDA | Chartwell RX, LLC | 62135-196 | 62135-196-24 | 2 TRAY in 1 BOX (62135-196-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-196-45) |
VALPROIC ACID | valproic acid | SYRUP;ORAL | 075782 | ANDA | Chartwell RX, LLC | 62135-196 | 62135-196-47 | 473 mL in 1 BOTTLE (62135-196-47) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 250MG/5ML | ||||
Approval Date: | Dec 22, 2000 | TE: | AA | RLD: | No |
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