FDA APPLICATION 21487 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Product List 2022

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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

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

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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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01 2ABBVIE

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01 2TABLET;ORAL

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01 2NAMENDA

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Brand Name : NAMENDA

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RLD : Yes

TE Code : AB

MEMANTINE HYDROCHLORIDE

Dosage Form : TABLET; ORAL

Proprietary Name : NAMENDA

Dosage Strength : 5MG

Approval Date : 2003-10-16

Application Number : 21487

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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Brand Name : NAMENDA

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RLD : Yes

TE Code : AB

MEMANTINE HYDROCHLORIDE

Dosage Form : TABLET; ORAL

Proprietary Name : NAMENDA

Dosage Strength : 10MG

Approval Date : 2003-10-16

Application Number : 21487

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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