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Setid Bfc8bd60 D228 45a0 93fa 2166d1324c77 Applno 208723 Form Powder Intravenous Dosage Eq 175mg Base Vial - Drug Product Composition: Calcium Levofolinate

Calcium Levofolinate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

13 API Suppliers, 5 USDMF, 3 CEP/COS, 5 JDMF, 2 KDMF, 6 NDC API, 5 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

61 FDF Dossiers, 22 FDA Orange Book, 25 Europe, 9 Canada, 2 South Africa, 3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INTRAVENOUS - EQ 50MG BASE/VIAL, POWDER;INTRAVENOUS - EQ 175MG BASE/VIAL

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 1 Gangwal Healthcare, 1 Pfanstiehl, 1 Kirsch Pharma, 3 Actylis, 1 BASF, 2 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 1 Kerry, 2 Microlex e.U, 1 Pluviaendo, 3 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

17 Fillers, Diluents & Binders, 12 Chewable & Orodispersible Aids, 10 Taste Masking, 10 Direct Compression, 8 Parenteral, 7 Disintegrants & Superdisintegrants, 3 Co-Processed Excipients, 3 Granulation, 1 Solubilizers, 1 Thickeners and Stabilizers

DIGITAL CONTENT

9 News #PharmaBuzz

9 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 21 Regulatory FDF Prices

MARKET PLACE

4 APIs

4 APIs

REF. STANDARDS & IMPURITIES

2 EDQM

2 EDQM

$ Xls

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USFDA APPLICATION NUMBER - 208723 / DOSAGE - POWDER;INTRAVENOUS - EQ 175MG BASE/VIAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOLEUCOVORIN CALCIUM(UNII: 778XL6VBS8) (LEVOLEUCOVORIN - UNII:990S25980Y)	LEVOLEUCOVORIN	10mg in 1

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.
HYDROCHLORIC ACID(QTT17582CB)
MANNITOL(3OWL53L36A)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)

Setid Bfc8bd60 D228 45a0 93fa 2166d1324c77 Applno 208723 Form Powder Intravenous Dosage Eq 175mg Base Vial - Drug Product Composition: Calcium Levofolinate

Calcium Levofolinate

Calcium Levofolinate

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

13 API Suppliers

5 USDMF

3 CEP/COS

5 JDMF

2 KDMF

6 NDC API

5 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

9 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

61 FDF Dossiers

22 FDA Orange Book

25 Europe

9 Canada

2 South Africa

3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INTRAVENOUS - EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

POWDER;INTRAVENOUS - EQ 50MG BASE/VIAL

POWDER;INTRAVENOUS - EQ 175MG BASE/VIAL

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

13 SPI Pharma

1 Gangwal Healthcare

1 Pfanstiehl

1 Kirsch Pharma

3 Actylis

1 BASF

2 Gangwal Chemicals

1 Ingredion Pharma Solutions

1 Kerry

2 Microlex e.U

1 Pluviaendo

3 Roquette

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

17 Fillers, Diluents & Binders

12 Chewable & Orodispersible Aids

10 Taste Masking

10 Direct Compression

8 Parenteral

7 Disintegrants & Superdisintegrants

3 Co-Processed Excipients

3 Granulation

1 Solubilizers

1 Thickeners and Stabilizers

DIGITAL CONTENT

9 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions

21 Regulatory FDF Prices

MARKET PLACE

4 APIs

REF. STANDARDS & IMPURITIES

2 EDQM

Filters

SOLUTION;INTRAVENOUS - EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INTRAVENOUS - EQ 250MG BASE/25ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons