Methotrexate - Abitrexate | 11719 | INJECTABLE;INJECTION | EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

Methotrexate - Abitrexate

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ACTIVE PHARMA INGREDIENTS

54 API Suppliers, 22 USDMF, 8 CEP/COS, 4 JDMF, 3 EU WC, 10 NDC API, 30 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

169 Drugs in Development

169 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

859 FDF Dossiers, 128 FDA Orange Book, 545 Europe, 59 Canada, 59 Australia, 13 South Africa, 55 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 100MG BASE/VIAL, INJECTABLE;INJECTION - EQ 1GM BASE/VIAL, INJECTABLE;INJECTION - EQ 1GM BASE/40ML (EQ 25MG BASE/ML), INJECTABLE;INJECTION - EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML), INJECTABLE;INJECTION - EQ 2.5MG BASE/ML, INJECTABLE;INJECTION - EQ 20MG BASE/VIAL, INJECTABLE;INJECTION - EQ 20MG BASE/2ML (EQ 10MG BASE/ML), INJECTABLE;INJECTION - EQ 25MG BASE/ML, INJECTABLE;INJECTION - EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 50MG BASE/VIAL, INJECTABLE;INJECTION - EQ 50MG BASE/2ML (EQ 25MG BASE/ML), SOLUTION;SUBCUTANEOUS - 10MG/0.4ML (10MG/0.4ML), SOLUTION;SUBCUTANEOUS - 12.5MG/0.5ML (12.5MG/0.5ML), SOLUTION;SUBCUTANEOUS - 15MG/0.6ML (15MG/0.6ML), SOLUTION;SUBCUTANEOUS - 17.5MG/0.7ML (17.5MG/0.7ML), SOLUTION;SUBCUTANEOUS - 20MG/0.8ML (20MG/0.8ML), SOLUTION;SUBCUTANEOUS - 22.5MG/ML (22.5MG/ML), SOLUTION;SUBCUTANEOUS - 25MG/1ML (25MG/1ML), SOLUTION;SUBCUTANEOUS - 7.5MG/0.3ML (7.5MG/0.3ML), TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 4 SPI Pharma, 5 DKSH, 1 Pharm-RX Chemical, 5 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 4 Kirsch Pharma, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 3 Finar, 9 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem

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PATENTS & EXCLUSIVITIES

144 US Patents

144 US Patents

REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 11719 / DOSAGE - INJECTABLE;INJECTION - EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHOTREXATE SODIUM(UNII: 3IG1E710ZN) (METHOTREXATE - UNII:YL5FZ2Y5U1)	METHOTREXATE	25mg in 1

Inactive Ingredients

Ingredient Name	Hospira, Inc.	Mylan Institutional LLC	Pfizer Laboratories Div Pfizer Inc.	Sandoz Inc	Teva Parenteral Medicines, Inc.	ThyMoorgan GmbH Pharmazir & Co. K.G
HYDROCHLORIC ACID(QTT17582CB)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)
WATER(059QF0KO0R)

Drug Product Composition: Methotrexate - Abitrexate