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Setid 76146a72 05fe 4804 A9c2 Df573c97d9cb Applno 19667 Form Injectable Injection Dosage Eq 0 5mg Base Ml - Drug Product Composition: Octreotide

Octreotide

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ACTIVE PHARMA INGREDIENTS

61 API Suppliers, 27 USDMF, 9 CEP/COS, 4 JDMF, 8 EU WC, 1 KDMF, 21 NDC API, 33 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

31 Drugs in Development

31 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

335 FDF Dossiers, 61 FDA Orange Book, 187 Europe, 11 Canada, 48 Australia, 8 South Africa, 20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 0.05MG BASE/ML, INJECTABLE;INJECTION - EQ 0.1MG BASE/ML, INJECTABLE;INJECTION - EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 0.5MG BASE/ML, INJECTABLE;INJECTION - EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;SUBCUTANEOUS - EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 14 SPI Pharma, 1 Gangwal Healthcare, 1 Pfanstiehl, 3 Kirsch Pharma, 2 Actylis, 1 BASF, 1 Finar, 2 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 1 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, 12 Chewable & Orodispersible Aids, 10 Parenteral, 10 Direct Compression, 10 Taste Masking, 7 Disintegrants & Superdisintegrants, 3 Granulation, 3 Co-Processed Excipients, 1 API Stability Enhancers, 1 Thickeners and Stabilizers, 1 Solubilizers, 1 Topical

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 42 News #PharmaBuzz

GLOBAL SALES INFORMATION

12 US Medicaid Prescriptions, 59 Regulatory FDF Prices, 11 Annual Reports

MARKET PLACE

20 APIs, 16 FDF Dossiers

PATENTS & EXCLUSIVITIES

29 US Patents, 1 US Exclusivities, 7 Health Canada Patents

REF. STANDARDS & IMPURITIES

6 Others

6 Others

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USFDA APPLICATION NUMBER - 19667 / DOSAGE - INJECTABLE;INJECTION - EQ 0.5MG BASE/ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTREOTIDE ACETATE(UNII: 75R0U2568I) (OCTREOTIDE - UNII:RWM8CCW8GP)	OCTREOTIDE	1000ug in 1 \| 200ug in 1

Inactive Ingredients

Ingredient Name	Heritage Pharmaceuticals Inc.	Sagent Pharmaceuticals	Teva Parenteral Medicines, Inc.	Sandoz Inc	Sun Pharmaceutical Industries Limited
acetic acid(Q40Q9N063P)
LACTIC ACID(33X04XA5AT)
MANNITOL(3OWL53L36A)
phenol(339NCG44TV)
sodium acetate(4550K0SC9B)
SODIUM BICARBONATE(8MDF5V39QO)
SODIUM CHLORIDE(451W47IQ8X)
WATER(059QF0KO0R)

Setid 76146a72 05fe 4804 A9c2 Df573c97d9cb Applno 19667 Form Injectable Injection Dosage Eq 0 5mg Base Ml - Drug Product Composition: Octreotide

Octreotide

Octreotide

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

61 API Suppliers

27 USDMF

9 CEP/COS

4 JDMF

8 EU WC

1 KDMF

21 NDC API

33 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

31 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

335 FDF Dossiers

61 FDA Orange Book

187 Europe

11 Canada

48 Australia

8 South Africa

20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 0.05MG BASE/ML

INJECTABLE;INJECTION - EQ 0.1MG BASE/ML

INJECTABLE;INJECTION - EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 0.5MG BASE/ML

INJECTABLE;INJECTION - EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;SUBCUTANEOUS - EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

14 SPI Pharma

1 Gangwal Healthcare

1 Pfanstiehl

3 Kirsch Pharma

2 Actylis

1 BASF

1 Finar

2 Gangwal Chemicals

1 Ingredion Pharma Solutions

1 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

12 Chewable & Orodispersible Aids

10 Parenteral

10 Direct Compression

10 Taste Masking

7 Disintegrants & Superdisintegrants

3 Granulation

3 Co-Processed Excipients

1 API Stability Enhancers

1 Thickeners and Stabilizers

1 Solubilizers

1 Topical

DIGITAL CONTENT

1 Data Compilation #PharmaFlow

42 News #PharmaBuzz

GLOBAL SALES INFORMATION

12 US Medicaid Prescriptions

59 Regulatory FDF Prices

11 Annual Reports

MARKET PLACE

20 APIs

16 FDF Dossiers

PATENTS & EXCLUSIVITIES

29 US Patents

1 US Exclusivities

INJECTABLE;INJECTION - EQ 0.2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons