FDA APPLICATION 19680 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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EVENTS

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Product List 2022

Product List 2022

DIGITAL CONTENT

1 CORPORATE CONTENT #SupplierSpotlight, 12 DATA COMPILATION #PharmaFlow, 2653 NEWS #PharmaBuzz

1 CORPORATE CONTENT #SupplierSpotlight
12 DATA COMPILATION #PharmaFlow
2653 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

13 All APIs, 7 USDMF, 6 CEP/COS, 7 KDMF, 7 NDC API, 8 Listed APIs

13 All APIs
7 USDMF
6 CEP/COS
7 KDMF
7 NDC API
8 Listed APIs

DEVELOPMENTS

306 Drugs in Development

306 Drugs in Development

FINISHED DOSAGE FORMULATIONS

832 FDF Dossiers, 287 FDA Orange Book, 148 Europe, 132 Canada, 202 Australia, 63 South Africa

832 FDF Dossiers
287 FDA Orange Book
148 Europe
132 Canada
202 Australia
63 South Africa

INSPECTIONS & REGISTRATIONS

96 FDA, 39 EDQM, 2 GDUFA

96 FDA
39 EDQM
2 GDUFA

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filter Applicant Reset all filters

1 All

01 1ABBVIE

filter Dosage Reset all filters

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01 1CAPSULE, DELAYED REL PELLETS;ORAL

filter Regulatory Info Reset all filters

1 All

01 1RX

filter Brand Name Reset all filters

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01 1DEPAKOTE

filter RLD Reset all filters

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01 1Yes

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Brand Name : DEPAKOTE

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RLD : Yes

TE Code : AB

DIVALPROEX SODIUM

Dosage Form : CAPSULE, DELAYED REL PELLETS; ...

Proprietary Name : DEPAKOTE

Dosage Strength : EQ 125MG VALPROIC ACID

Approval Date : 1989-09-12

Application Number : 19680

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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