FDA APPLICATION 16851 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Product List 2022

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DIGITAL CONTENT

1 CORPORATE CONTENT #SupplierSpotlight, 11 DATA COMPILATION #PharmaFlow, 2638 NEWS #PharmaBuzz

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2638 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
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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 1SUSPENSION/DROPS;OPHTHALMIC

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01 1RX

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01 1FML

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01 1Yes

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Brand Name : FML

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RLD : Yes

TE Code : AB

FLUOROMETHOLONE

Dosage Form : SUSPENSION/DROPS; OPHTHALMIC

Proprietary Name : FML

Dosage Strength : 0.1%

Approval Date : 1982-07-28

Application Number : 16851

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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