FDA APPLICATION 50775 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Product List 2022

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

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DEVELOPMENTS

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

830 FDF Dossiers
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 1TABLET, EXTENDED RELEASE;ORAL

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01 1DISCN

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01 1BIAXIN XL

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01 1Yes

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Brand Name : BIAXIN XL

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RLD : Yes

TE Code :

CLARITHROMYCIN

Dosage Form : TABLET, EXTENDED RELEASE; ORAL

Proprietary Name : BIAXIN XL

Dosage Strength : 500MG **Federal Register...

Approval Date : 2000-03-03

Application Number : 50775

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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