FDA APPLICATION 21883 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Product List 2022

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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
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303 Drugs in Development

303 Drugs in Development

FINISHED DOSAGE FORMULATIONS

830 FDF Dossiers, 285 FDA Orange Book, 148 Europe, 132 Canada, 202 Australia, 63 South Africa

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285 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 1ABBVIE

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01 1POWDER;INTRAVENOUS

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01 1RX

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01 1DALVANCE

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01 1Yes

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Brand Name : DALVANCE

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RLD : Yes

TE Code :

DALBAVANCIN HYDROCHLORIDE

Dosage Form : POWDER; INTRAVENOUS

Proprietary Name : DALVANCE

Dosage Strength : EQ 500MG BASE/VIAL

Approval Date : 2014-05-23

Application Number : 21883

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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