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

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306 Drugs in Development

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

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96 FDA, 39 EDQM, 2 GDUFA

96 FDA
39 EDQM
2 GDUFA

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filter Applicant Reset all filters

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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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