ACTIQ

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 13 USDMF, 12 CEP/COS, 4 JDMF, 2 EU WC, 4 KDMF, 15 NDC API, 16 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

495 FDF Dossiers, 77 FDA Orange Book, 374 Europe, 13 Canada, 3 South Africa, 28 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE, TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 18 SPI Pharma, 2 DKSH, 2 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 5 Kirsch Pharma, 1 ACG Worldwide, 6 Actylis, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 BASF, 1 CD Formulation, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Finar, 5 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 4 Ideal Cures, 5 Ingredion Pharma Solutions, 11 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 8 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

55 Fillers, Diluents & Binders, 38 Coating Systems & Additives, 30 Disintegrants & Superdisintegrants, 27 Direct Compression, 21 Thickeners and Stabilizers, 19 Taste Masking, 18 Chewable & Orodispersible Aids, 17 Controlled & Modified Release, 16 Granulation, 13 Parenteral, 12 Co-Processed Excipients, 10 Lubricants & Glidants, 9 Film Formers & Plasticizers, 6 Solubilizers, 5 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Emulsifying Agents, 3 Topical, 2 Coloring Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 36 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 34 Regulatory FDF Prices, 8 Annual Reports

MARKET PLACE

13 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

18 US Patents, 17 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 Others

$ Xls

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USFDA APPLICATION NUMBER - 22569 / DOSAGE - SPRAY, METERED;NASAL - EQ 0.4MG BASE **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
FENTANYL CITRATE(UNII: MUN5LYG46H) (FENTANYL - UNII:UF599785JZ)	FENTANYL	400ug \| 300ug \| 100ug

Inactive Ingredients

Ingredient Name	Depomed, Inc.
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
COPOVIDONE K25-31(D9C330MD8B)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
PECTIN(89NA02M4RX)
PHENYLETHYL ALCOHOL(ML9LGA7468)
PROPYLPARABEN(Z8IX2SC1OH)
SUCROSE(C151H8M554)
WATER(059QF0KO0R)

Setid 9dcaff31 1653 11e3 8ffd 0800200c9a66 Applno 22569 Form Spray Metered Nasal Dosage Eq 0 4mg Base - Drug Product Composition: ACTIQ

ACTIQ

ACTIQ

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

39 API Suppliers

13 USDMF

12 CEP/COS

4 JDMF

2 EU WC

4 KDMF

15 NDC API

16 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

495 FDF Dossiers

77 FDA Orange Book

374 Europe

13 Canada

3 South Africa

28 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE

TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc

18 SPI Pharma

2 DKSH

2 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

2 Pfanstiehl

5 Kirsch Pharma

1 ACG Worldwide

6 Actylis

1 Alcedo Pharmachem

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

4 BASF

1 CD Formulation

10 Corel Pharma Chem

4 DFE Pharma

1 Finar

5 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

4 Ideal Cures

5 Ingredion Pharma Solutions

11 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

2 Nitika Pharmaceutical Specialities

2 Novo Excipients

2 Pharmatrans-Sanaq

4 Pluviaendo

4 Prachin Chemical

TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons