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Drug Product Composition: Levoleucovorin Calcium

Levoleucovorin Calcium

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ACTIVE PHARMA INGREDIENTS

9 API Suppliers, 4 USDMF, 3 CEP/COS, 5 JDMF, 2 KDMF, 6 NDC API, 4 Listed Suppliers, $ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

60 FDF Dossiers, 22 FDA Orange Book, 25 Europe, 8 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- EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INTRAVENOUS - EQ 50MG BASE/VIAL, POWDER;INTRAVENOUS - EQ 175MG BASE/VIAL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, 12 SPI Pharma, 1 Faran Shimi Pharmaceutical, 1 Pfanstiehl, 3 Actylis, 1 BASF, 2 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 2 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, 10 Chewable & Orodispersible Aids, 9 Taste Masking, 9 Direct Compression, 7 Parenteral, 4 Co-Processed Excipients, 3 Granulation, 3 Disintegrants & Superdisintegrants, 1 API Stability Enhancers, 1 Thickeners and Stabilizers

DIGITAL CONTENT

9 NEWS #PharmaBuzz

9 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 21 Finished Drug Prices

MARKET PLACE

4 APIs

4 APIs

REF. STANDARDS & IMPURITIES

2 EDQM

2 EDQM

$ Xls

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USFDA APPLICATION NUMBER - 20140 / DOSAGE - 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- EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOLEUCOVORIN CALCIUM(UNII: 778XL6VBS8) (LEVOLEUCOVORIN - UNII:990S25980Y)	LEVOLEUCOVORIN	10mg in 1 \| 50mg in 5

Inactive Ingredients

Ingredient Name	Spectrum Pharmaceuticals, Inc.
HYDROCHLORIC ACID(QTT17582CB)
MANNITOL(3OWL53L36A)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)
WATER(059QF0KO0R)

Drug Product Composition: Levoleucovorin Calcium

Levoleucovorin Calcium

Levoleucovorin Calcium

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

9 API Suppliers

4 USDMF

3 CEP/COS

5 JDMF

2 KDMF

6 NDC API

4 Listed Suppliers

$ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

60 FDF Dossiers

22 FDA Orange Book

25 Europe

8 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

12 SPI Pharma

1 Faran Shimi Pharmaceutical

1 Pfanstiehl

3 Actylis

1 BASF

2 Gangwal Chemicals

1 Ingredion Pharma Solutions

2 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

10 Chewable & Orodispersible Aids

9 Taste Masking

9 Direct Compression

7 Parenteral

4 Co-Processed Excipients

3 Granulation

3 Disintegrants & Superdisintegrants

1 API Stability Enhancers

1 Thickeners and Stabilizers

DIGITAL CONTENT

9 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

21 Finished Drug 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