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1261 FDF Dossiers, 113 FDA Orange Book, 668 Europe, 62 Canada, 80 Australia, 83 South Africa, 255 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 12.5MG;40MG, TABLET;ORAL - 12.5MG;80MG, TABLET;ORAL - 25MG;80MG, TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 19 SPI Pharma, 8 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 1 Panvo Organics, 2 Cerata Pharmaceuticals LLP, 3 Dr. Paul Lohmann GmbH & Co. KGaA, 1 ACG Worldwide, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 14 BASF, 1 CD Formulation, 10 Corel Pharma Chem, 7 DFE Pharma, 8 Gangwal Chemicals, 1 Gloria Interchem, 4 Ideal Cures, 5 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Neelkanth MineChem, 3 Nitika Pharmaceutical Specialities, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Pharmachem, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 29 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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USFDA APPLICATION NUMBER - 20850 / DOSAGE - TABLET;ORAL - 20MG **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
TELMISARTAN(UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)	TELMISARTAN	80mg

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Setid E29933dd 3e4e 4c43 973c 67e7398bf803 Applno 20850 Form Tablet Oral Dosage 20mg - Drug Product Composition: TLS

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ACTIVE PHARMA INGREDIENTS

160 API Suppliers

41 USDMF

43 CEP/COS

19 JDMF

22 EU WC

49 KDMF

21 NDC API

74 Listed Suppliers

DEVELOPMENTS

119 Drugs in Development

INTERMEDIATES

54 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1261 FDF Dossiers

113 FDA Orange Book

668 Europe

62 Canada

80 Australia

83 South Africa

255 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 40MG

TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 12.5MG;40MG

TABLET;ORAL - 12.5MG;80MG

TABLET;ORAL - 25MG;80MG

TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

2 Rochem International Inc

19 SPI Pharma

8 Boai NKY Pharmaceuticals Ltd

7 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

1 Pfanstiehl

1 Panvo Organics

2 Cerata Pharmaceuticals LLP

3 Dr. Paul Lohmann GmbH & Co. KGaA

1 ACG Worldwide

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

14 BASF

1 CD Formulation

10 Corel Pharma Chem

7 DFE Pharma

8 Gangwal Chemicals

1 Gloria Interchem

4 Ideal Cures

5 Ingredion Pharma Solutions

24 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

15 Microlex e.U

1 Neelkanth MineChem

3 Nitika Pharmaceutical Specialities

3 Novo Excipients

5 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Pharmachem

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

29 Roquette

7 Seppic

7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

TABLET;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons