Mylan-Metformin

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ACTIVE PHARMA INGREDIENTS

178 API Suppliers, 57 USDMF, 40 CEP/COS, 13 JDMF, 28 EU WC, 101 KDMF, 40 NDC API, 47 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

213 Drugs in Development

213 Drugs in Development

FINISHED DOSAGE FORMULATIONS

2255 FDF Dossiers, 447 FDA Orange Book, 836 Europe, 142 Canada, 140 Australia, 150 South Africa, 540 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;1GM, TABLET;ORAL - 2.5MG;500MG, TABLET;ORAL - 2.5MG;850MG, TABLET;ORAL - EQ 12.5MG BASE;1GM, TABLET;ORAL - EQ 12.5MG BASE;500MG, TABLET;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM, TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG, TABLET, EXTENDED RELEASE;ORAL - 50MG;1GM, TABLET, EXTENDED RELEASE;ORAL - 50MG;500MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 500MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 500MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 1GM, TABLET, EXTENDED RELEASE;ORAL - 500MG, TABLET;ORAL - 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG;EQ 15MG BASE, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 15MG BASE, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 30MG BASE, TABLET;ORAL - 1GM;EQ 50MG BASE, TABLET;ORAL - 500MG;EQ 50MG BASE, TABLET;ORAL - 500MG;1MG, TABLET;ORAL - 500MG;2MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 2 Minakem, 8 Evonik, 7 Rochem International Inc, 23 SPI Pharma, 19 DKSH, 2 Pharm-RX Chemical, 13 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 12 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 6 Kirsch Pharma, 1 ACG Worldwide, 12 Actylis, 3 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 1 Avesta Pharma, 38 BASF, 1 Bioplus Life Sciences, 2 CD Formulation, 2 Clariant, 27 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 5 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 5 Lubrizol Life Science Health, 22 Microlex e.U, 2 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 11 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 35 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 2 Zhejiang Huakang Pharmaceutical

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USFDA APPLICATION NUMBER - 201281 / DOSAGE - TABLET;ORAL - 2.5MG;850MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LINAGLIPTIN(UNII: 3X29ZEJ4R2) (LINAGLIPTIN - UNII:3X29ZEJ4R2)	LINAGLIPTIN	2.5mg
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	1000mg

Setid 3010d452 Dab5 44c5 B8d0 Bdc725679f07 Applno 201281 Form Tablet Oral Dosage 2 5mg 850mg - Drug Product Composition: Mylan-Metformin

Mylan-Metformin

Mylan-Metformin

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

178 API Suppliers

57 USDMF

40 CEP/COS

13 JDMF

28 EU WC

101 KDMF

40 NDC API

47 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

213 Drugs in Development

FINISHED DOSAGE FORMULATIONS

2255 FDF Dossiers

447 FDA Orange Book

836 Europe

142 Canada

140 Australia

150 South Africa

540 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 2.5MG;1GM

TABLET;ORAL - 2.5MG;500MG

TABLET;ORAL - 2.5MG;850MG

TABLET;ORAL - EQ 12.5MG BASE;1GM

TABLET;ORAL - EQ 12.5MG BASE;500MG

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

TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM

TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG

TABLET, EXTENDED RELEASE;ORAL - 50MG;1GM

TABLET, EXTENDED RELEASE;ORAL - 50MG;500MG

TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION, EXTENDED RELEASE;ORAL - 500MG/5ML

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

TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;ORAL - 500MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 1GM

TABLET, EXTENDED RELEASE;ORAL - 500MG

TABLET;ORAL - 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 850MG;EQ 15MG BASE

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 15MG BASE

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 30MG BASE

TABLET;ORAL - 1GM;EQ 50MG BASE

TABLET;ORAL - 500MG;EQ 50MG BASE

TABLET;ORAL - 500MG;1MG

TABLET;ORAL - 500MG;2MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

2 Minakem

8 Evonik

7 Rochem International Inc

23 SPI Pharma

19 DKSH

2 Pharm-RX Chemical

13 Boai NKY Pharmaceuticals Ltd

9 Gangwal Healthcare

12 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

6 Kirsch Pharma

1 ACG Worldwide

12 Actylis

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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

TABLET;ORAL - 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 850MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 1.25MG;250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 2.5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;ORAL - 500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons