Naloxone

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55 Drugs in Development

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5 API Suppliers

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310 FDF Dossiers, 161 FDA Orange Book, 83 Europe, 13 Canada, 16 Australia, 7 South Africa, 30 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE, FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE, FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.4MG/0.4ML (0.4MG/0.4ML), TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML), FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem, 4 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 1 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 3 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 10 Actylis, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 16 BASF, 1 Bioplus Life Sciences, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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USFDA APPLICATION NUMBER - 209862 / DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NALOXONE HYDROCHLORIDE(UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE HYDROCHLORIDE	2mg in 0.4

Inactive Ingredients

Ingredient Name	IJ Therapeutics, LLC	kaleo, Inc.
HYDROCHLORIC ACID(QTT17582CB)
SODIUM CHLORIDE(451W47IQ8X)
WATER(059QF0KO0R)

Drug Product Composition: Naloxone

Naloxone

Naloxone

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers

13 USDMF

11 CEP/COS

1 JDMF

2 EU WC

2 KDMF

19 NDC API

17 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

55 Drugs in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

5 API Suppliers

FINISHED DOSAGE FORMULATIONS

310 FDF Dossiers

161 FDA Orange Book

83 Europe

13 Canada

16 Australia

7 South Africa

30 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE

FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE

FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.4MG/0.4ML (0.4MG/0.4ML)

TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML)

FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE

FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE

FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE

FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem

4 Rochem International Inc

17 SPI Pharma

2 Seqens

1 DKSH

2 Jai Radhe Sales

1 Pharm-RX Chemical

3 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

14 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 ACG Worldwide

10 Actylis

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

16 BASF

1 Bioplus Life Sciences

10 Corel Pharma Chem

6 DFE Pharma

2 Finar

7 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

37 Kerry

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 NEWEDGE Overseas

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons