FDA APPLICATION 91356 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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VISIT THE VIRTUAL BOOTH, Contact Details

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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Product List 2024, Corporate Presentation, Manufacturing Sites and R&D Center, GMP Certificate 2021

Product List 2024
Corporate Presentation
Manufacturing Sites and R&D Center
GMP Certificate 2021

DIGITAL CONTENT

4 CORPORATE CONTENT #SupplierSpotlight, 251 NEWS #PharmaBuzz

4 CORPORATE CONTENT #SupplierSpotlight
251 NEWS #PharmaBuzz

DEVELOPMENTS

46 Drugs in Development

46 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1147 FDF Dossiers, 488 FDA Orange Book, 2 Europe, 1 Canada, 77 Australia, 70 South Africa, 509 Listed Dossiers

1147 FDF Dossiers
488 FDA Orange Book
2 Europe
1 Canada
77 Australia
70 South Africa
509 Listed Dossiers

KEY PRODUCTS

Cyclosporine, Hydrocortisone, Hydrocortisone Acetate, Hydrocortisone Butyrate, Hydrocortisone Sodium Succinate, Hydrocortisone Valerate, Macrogol, Oseltamivir Phosphate, Vancomycin Hydrochloride

Cyclosporine
Hydrocortisone
Hydrocortisone Acetate
Hydrocortisone Butyrate
Hydrocortisone Sodium Succinate
Hydrocortisone Valerate
Macrogol
Oseltamivir Phosphate
Vancomycin Hydrochloride

INSPECTIONS & REGISTRATIONS

26 FDA, 12 EDQM, 2 WHO-GMP, 6 GDUFA

26 FDA
12 EDQM
2 WHO-GMP
6 GDUFA

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Dosage Form : CAPSULE; ORAL

Proprietary Name : CALCITRIOL

Dosage Strength : 0.25MCG

Approval Date : 2014-12-12

Application Number : 91356

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Brand Name : CALCITRIOL

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RLD : No

TE Code : AB

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Dosage Form : CAPSULE; ORAL

Proprietary Name : CALCITRIOL

Dosage Strength : 0.5MCG

Approval Date : 2014-12-12

Application Number : 91356

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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