Metformin

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32 Drugs in Development

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EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;1GM, TABLET;ORAL - 2.5MG;500MG, TABLET;ORAL - 2.5MG;850MG, TABLET;ORAL - EQ 12.5MG BASE;1GM,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- EQ 12.5MG BASE;500MG, TABLET;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM, TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG, TABLET, EXTENDED RELEASE;ORAL -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- 50MG;500MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 500MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM, TABLET, EXTENDED RELEASE;ORAL -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

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USFDA APPLICATION NUMBER - 21591 / DOSAGE - SOLUTION;ORAL - 500MG/5ML **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
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	500mg in 5

Inactive Ingredients

Ingredient Name	INNOVIDA PHARMACEUTIQUE CORPORATION
HYDROCHLORIC ACID(QTT17582CB)
POTASSIUM BICARBONATE(HM5Z15LEBN)
SACCHARIN CALCIUM(5101OP7P2I)
XYLITOL(VCQ006KQ1E)

Drug Product Composition: Metformin

Metformin

Metformin

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ACTIVE PHARMA INGREDIENTS

175 API Suppliers

56 USDMF

42 CEP/COS

13 JDMF

29 EU WC

96 KDMF

39 NDC API

43 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

32 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1931 FDF Dossiers

418 FDA Orange Book

534 Europe

136 Canada

132 Australia

145 South Africa

566 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

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

8 Rochem International Inc

23 SPI Pharma

19 DKSH

2 Pharm-RX Chemical

10 Faran Shimi Pharmaceutical

13 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

9 Gangwal Healthcare

12 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 Pramukh Pharmachem

1 Zeal MediPharma

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 - 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