Trandolapril

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ACTIVE PHARMA INGREDIENTS

16 API Suppliers, 7 USDMF, 6 CEP/COS, 3 JDMF, 2 EU WC, 4 NDC API, 6 Listed Suppliers, $ API Reference Price

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

111 FDF Dossiers, 33 FDA Orange Book, 17 Europe, 25 Canada, 24 Australia, 8 South Africa, 4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 5 SPI Pharma, 7 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 17 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 1 Finar, 7 Gangwal Chemicals, 5 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 16 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

53 Fillers, Diluents & Binders, 42 Coating Systems & Additives, 27 Direct Compression, 25 Granulation, 23 Controlled & Modified Release, 20 Thickeners and Stabilizers, 19 Lubricants & Glidants, 19 Disintegrants & Superdisintegrants, 12 Solubilizers, 12 Co-Processed Excipients, 9 Topical, 9 Chewable & Orodispersible Aids, 8 Film Formers & Plasticizers, 7 Taste Masking, 7 Rheology Modifiers, 5 Coloring Agents, 5 Empty Capsules, 5 API Stability Enhancers, 4 Emulsifying Agents, 4 Parenteral, 4 Vegetarian Capsules, 1 Surfactant & Foaming Agents

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USFDA APPLICATION NUMBER - 20528 / DOSAGE - TABLET;ORAL - 4MG **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
TRANDOLAPRIL(UNII: 1T0N3G9CRC) (TRANDOLAPRILAT - UNII:RR6866VL0O)	TRANDOLAPRIL	4mg \| 2mg \| 1mg

Inactive Ingredients

Ingredient Name	AbbVie Inc.
CROSCARMELLOSE SODIUM(M28OL1HH48)
FERRIC OXIDE RED(1K09F3G675)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
POVIDONES(FZ989GH94E)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
STARCH, CORN(O8232NY3SJ)

Setid 5ad67ea2 409c 4f52 A9b8 38216209609a Applno 20528 Form Tablet Oral Dosage 4mg - Drug Product Composition: Trandolapril

Trandolapril

Trandolapril

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

16 API Suppliers

7 USDMF

6 CEP/COS

3 JDMF

2 EU WC

4 NDC API

6 Listed Suppliers

$ API Reference Price

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

111 FDF Dossiers

33 FDA Orange Book

17 Europe

25 Canada

24 Australia

8 South Africa

4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

TABLET;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

5 SPI Pharma

7 DKSH

4 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

1 ACG Worldwide

3 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

17 BASF

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

1 Finar

7 Gangwal Chemicals

5 Ideal Cures

3 Ingredion Pharma Solutions

24 Kerry

2 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

12 Microlex e.U

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

2 Novo Excipients

3 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

16 Roquette

7 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

10 Sigachi Industries

3 Silverline Chemicals

2 The Dow Chemical Company

1 Ulanqab Kema New Material

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

53 Fillers, Diluents & Binders

42 Coating Systems & Additives

27 Direct Compression

25 Granulation

23 Controlled & Modified Release

TABLET;ORAL - 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons