MYKACET-1

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

90 API Suppliers, 28 USDMF, 12 CEP/COS, 5 JDMF, 10 EU WC, 21 KDMF, 30 NDC API, 1 VMF, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

46 Drugs in Development

46 Drugs in Development

FINISHED DOSAGE FORMULATIONS

330 FDF Dossiers, 232 FDA Orange Book, 54 Europe, 17 Canada, 2 South Africa, 25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;TOPICAL - 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 10MG/ML, SPRAY;TOPICAL - 0.147MG/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 40MG/ML, INJECTABLE;INJECTION - 80MG/ML, SPRAY, METERED;NASAL - 0.055MG/SPRAY, FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR - 32MG/VIAL, CREAM;TOPICAL - 0.025%, CREAM;TOPICAL - 0.1%, CREAM;TOPICAL - 0.5%, OINTMENT;TOPICAL - 0.025%, OINTMENT;TOPICAL - 0.1%, OINTMENT;TOPICAL - 0.5%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 4 Rochem International Inc, 9 SPI Pharma, 13 DKSH, 1 Pharm-RX Chemical, 3 Gangwal Healthcare, 13 Nanjing Well Pharmaceutical, 12 Kirsch Pharma, 4 ACG Worldwide, 15 Actylis, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 22 BASF, 3 CD Formulation, 1 Clariant, 2 DFE Pharma, 2 Esteem Industries, 6 Finar, 12 Gangwal Chemicals, 1 Ideal Cures, 2 Kerry, 2 Keval Exports, 1 Kima Chemical, 3 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 1 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 1 Prachin Chemical, 1 Qualicaps, 19 Roquette, 12 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 1 Silverline Chemicals, 1 The Dow Chemical Company, 1 Valens Pharmachem, 1 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

45 Thickeners and Stabilizers, 44 Topical, 40 Solubilizers, 37 Parenteral, 28 Fillers, Diluents & Binders, 19 Film Formers & Plasticizers, 18 Emulsifying Agents, 15 Surfactant & Foaming Agents, 14 Coating Systems & Additives, 12 Direct Compression, 11 Co-Processed Excipients, 11 Rheology Modifiers, 10 Controlled & Modified Release, 9 Taste Masking, 8 Empty Capsules, 8 Granulation, 7 Chewable & Orodispersible Aids, 5 Disintegrants & Superdisintegrants, 4 Lubricants & Glidants, 3 API Stability Enhancers, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

109 News #PharmaBuzz

109 News #PharmaBuzz

GLOBAL SALES INFORMATION

53 US Medicaid Prescriptions, 32 Regulatory FDF Prices

MARKET PLACE

30 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

8 US Patents, 5 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 2 JP

$ Xls

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USFDA APPLICATION NUMBER - 14901 / DOSAGE - INJECTABLE;INJECTION - 40MG/ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRIAMCINOLONE ACETONIDE(UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)	TRIAMCINOLONE ACETONIDE	40mg

Inactive Ingredients

Ingredient Name	Proficient Rx LP	RX PHARMA-PACK, INC.	Preferred Pharmaceuticals Inc.	REMEDYREPACK INC.	Sandoz Inc	Terrain Pharmaceuticals	REMEDYREPACK INC.
ALCOHOL(3K9958V90M)
BENZYL ALCOHOL(LKG8494WBH)
carboxymethylcellulose sodium(K679OBS311)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
ENGLISH LAVENDER OIL(ZBP1YXW0H8)
FD&C RED NO. 40(WZB9127XOA)
hydrochloric acid(QTT17582CB)
LAVENDER OIL(ZBP1YXW0H8)
LEMON OIL(I9GRO824LL)
LEMON(24RS0A988O)
METHYLPARABEN(A2I8C7HI9T)
NITROGEN(N762921K75)
NONOXYNOL-9(48Q180SH9T)
NUTMEG OIL(Z1CLM48948)
POLYSORBATE 80(6OZP39ZG8H)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM PHOSPHATE, DIBASIC(GR686LBA74)
WATER(059QF0KO0R)

Setid 7bda15b1 D50d 4b1a 83a2 D9a450961bcf Applno 14901 Form Injectable Injection Dosage 40mg Ml - Drug Product Composition: MYKACET-1

MYKACET-1

MYKACET-1

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

90 API Suppliers

28 USDMF

12 CEP/COS

5 JDMF

10 EU WC

21 KDMF

30 NDC API

1 VMF

36 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

46 Drugs in Development

FINISHED DOSAGE FORMULATIONS

330 FDF Dossiers

232 FDA Orange Book

54 Europe

17 Canada

2 South Africa

25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;TOPICAL - 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 10MG/ML

SPRAY;TOPICAL - 0.147MG/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 40MG/ML

INJECTABLE;INJECTION - 80MG/ML

SPRAY, METERED;NASAL - 0.055MG/SPRAY

FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR - 32MG/VIAL

CREAM;TOPICAL - 0.025%

CREAM;TOPICAL - 0.1%

CREAM;TOPICAL - 0.5%

OINTMENT;TOPICAL - 0.025%

OINTMENT;TOPICAL - 0.1%

OINTMENT;TOPICAL - 0.5%

RELATED EXCIPIENT COMPANIES

2 EUROAPI

4 Rochem International Inc

9 SPI Pharma

13 DKSH

1 Pharm-RX Chemical

3 Gangwal Healthcare

13 Nanjing Well Pharmaceutical

12 Kirsch Pharma

4 ACG Worldwide

15 Actylis

2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

22 BASF

3 CD Formulation

1 Clariant

2 DFE Pharma

2 Esteem Industries

6 Finar

12 Gangwal Chemicals

1 Ideal Cures

2 Kerry

2 Keval Exports

1 Kima Chemical

3 Lonza Capsugel

11 Microlex e.U

1 Nanjing Bold Chemical

1 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Pharmatrans-Sanaq

3 Pluviaendo

1 Prachin Chemical

1 Qualicaps

19 Roquette

12 Seppic

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

8 Sigachi Industries

CREAM;TOPICAL - 0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CREAM;TOPICAL - 0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY;TOPICAL - 0.147MG/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons