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01 9Sanofi

02 3AbbVie Inc

03 22care4

04 1AAIPharma Services Corp.

05 1AGIPS FARMACEUTICI Srl

06 1ALTER LABORATORIES SRL

07 6APIL

08 2AUROBINDO PHARMA USA

09 2Ababor Pharmaceuticals Sl

10 1Abacus Medicine

11 7Accord healthcare

12 6Actavis Inc

13 3Adamed Pharma

14 1Agips Farmaceutici

15 1Almus

16 1Alter Laboratories Sa

17 1Apotex Fermentation Inc.

18 11Apotex Inc

19 4Aristo Pharma GmbH

20 1Arrow Generics Ltd

21 1Auro Pharma Inc

22 11Aurobindo Pharma Limited

23 3Aurovitas Spain, Sau

24 1Biotech Laboratories Pty Ltd

25 2Bluefish Pharmaceuticals AB

26 1CRINOS SpA

27 2Cinfa

28 1Cinfa Laboratories Sa

29 2Cipla

30 2Combix Laboratories Slu

31 4DOC Generici

32 1DYMALIFE PHARMACEUTICAL SRL

33 2EG SpA

34 3EG Spa

35 1EPIFARMA Srl

36 1EURO-PHARMA SRL

37 2Ebb Medical

38 1Europharma

39 1FENIX PHARMA Soc.Coop.p.A.

40 1GENETIC SpA

41 2GERMED PHARMA Srl

42 3Genetic Spa

43 1Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd

44 3Hanlim Pharmaceuticals Inc

45 3IBN Savio

46 1IPSO PHARMA Srl

47 1Impax Laboratories

48 2Intas Pharmaceuticals

49 1Ivowen Ltd

50 3Jubilant Generics

51 2Karo Pharma

52 1Kern Pharma S.L.

53 2LABORATORIOS NORMON SA

54 1LANOVA FARMACEUTICI Srl

55 1Laboratoire Riva

56 1Laboratorios Alter

57 1Lanova Farmaceutici

58 4Macleods Pharmaceuticals Limited

59 1Medartuum

60 2Myungmoon Pharm. Co., LTD.

61 1NEOPHARMED GENTILI Srl

62 2Neuraxpharm

63 9ORIFARM GROUP AS

64 1Omnia L?kemedel Ab

65 2OrBion Pharmaceuticals

66 3Orchid Pharma

67 5PHARMOBEDIENT

68 1PRO DOC LIMITEE

69 1PROCTER & GAMBLE SRL

70 2Parallel Pharma Ab

71 2Paranova Pharmaceuticals Ab

72 1Pensa Pharma

73 1Pharma Dynamics

74 6Pharmascience Inc.

75 9Pharmathen SA

76 1ProCare Health

77 1RANBAXY LABORATORIES LIMITED

78 1Ratiopharm GmbH

79 2SANIS HEALTH INC

80 1SF Group

81 1SIVEM PHARMACEUTICALS ULC

82 1SPA (SOC.PRO.ANTIBIOTICI) SpA

83 1SPA - Antibiotic Products

84 10STADA Arzneimittel

85 12Sandoz B2B

86 8Sun Pharmaceutical Industries Limited

87 1TECNIGEN Srl

88 2Tecnimede

89 13Teva Pharmaceutical Industries

90 44Theramex

91 1Unimedic AB

92 12Viatris

93 4WAGNER PHARMACEUTICALS PTY LTD

94 8Warner Chilcott Company, LLC

95 1Yangtze River Pharmaceutical Group

96 1Zaklady Farmaceutyczne UNIA

97 1Zentiva

98 1Zydus Pharmaceuticals

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Deregistered

Registration Country : Sweden

Calcium Carbonate; Cholecalciferol; Risedronate Sodium

Brand Name : Avestra Combi D

Dosage Form : Film Coated Tablet

Dosage Strength : 35mg;1000mg;880IE

Packaging :

Approval Date : 13-10-2006

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

Sanofi Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Deregistered

Registration Country : Sweden

Calcium Carbonate; Cholecalciferol; Risedronate Sodium

Brand Name : Optinate Combi D

Dosage Form : Film Coated Tablet

Dosage Strength : 35mg;500mg;400IU

Packaging :

Approval Date : 17-12-2008

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

Sanofi Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Deregistered

Registration Country : Sweden

Calcium Carbonate; Cholecalciferol; Risedronate Sodium

Brand Name : Norsed Combi D

Dosage Form : Film Coated Tablet

Dosage Strength : 35mg;500mg;400IU

Packaging :

Approval Date : 21-08-2009

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

Sanofi Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Deregistered

Registration Country : Sweden

Calcium Carbonate; Cholecalciferol; Risedronate Sodium

Brand Name : Avestra Combi D

Dosage Form : Film Coated Tablet

Dosage Strength : 35mg;500mg;400IU

Packaging :

Approval Date : 20-11-2009

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

Sanofi Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Deregistered

Registration Country : Sweden

Calcium Carbonate; Risedronate Sodium

Brand Name : Avestra Combi

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 13-08-2004

Application Number : 2.00E+13

Regulatory Info : Deregistered

Registration Country : Sweden

Sanofi Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Deregistered

Registration Country : Sweden

Calcium Carbonate; Risedronate Sodium

Brand Name : Norsed Combi

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 13-08-2004

Application Number : 2.00E+13

Regulatory Info : Deregistered

Registration Country : Sweden

Sanofi Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Deregistered

Registration Country : Sweden

Risedronate Sodium

Brand Name : Avestra

Dosage Form : Film Coated Tablet

Dosage Strength : 30mg

Packaging :

Approval Date : 07-10-1999

Application Number : 2.00E+13

Regulatory Info : Deregistered

Registration Country : Sweden

Sanofi Company Banner

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Deregistered

Registration Country : Sweden

Risedronate Sodium

Brand Name : Norsed

Dosage Form : Film Coated Tablet

Dosage Strength : 5mg

Packaging :

Approval Date : 07-10-1999

Application Number : 2.00E+13

Regulatory Info : Deregistered

Registration Country : Sweden

Sanofi Company Banner

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Regulatory Info : Deregistered

Registration Country : Sweden

Risedronate Sodium

Brand Name : Norsed

Dosage Form : Film Coated Tablet

Dosage Strength : 30mg

Packaging :

Approval Date : 07-10-1999

Application Number : 2.00E+13

Regulatory Info : Deregistered

Registration Country : Sweden

Sanofi Company Banner

12

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Brand Name : ACTONEL DR

Dosage Form : TABLET (DELAYED-RELEASE)

Dosage Strength : 35MG

Packaging : 4

Approval Date :

Application Number : 2370417

Regulatory Info : PRESCRIPTION

Registration Country : Canada

Abbvie Company Banner

13

APIL

Country
PEGS Boston Summit
Not Confirmed
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APIL

Country
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PEGS Boston Summit
Not Confirmed

RISEDRONATE SODIUM

Brand Name : ACTONEL

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date : 1998-03-27

Application Number : 20835

Regulatory Info : DISCN

Registration Country : USA

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14

APIL

Country
PEGS Boston Summit
Not Confirmed
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APIL

Country
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PEGS Boston Summit
Not Confirmed

RISEDRONATE SODIUM

Brand Name : ACTONEL

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2000-04-14

Application Number : 20835

Regulatory Info : DISCN

Registration Country : USA

blank

15

APIL

Country
PEGS Boston Summit
Not Confirmed
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APIL

Country
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PEGS Boston Summit
Not Confirmed

RISEDRONATE SODIUM

Brand Name : ACTONEL

Dosage Form : TABLET;ORAL

Dosage Strength : 35MG

Packaging :

Approval Date : 2002-05-25

Application Number : 20835

Regulatory Info : RX

Registration Country : USA

blank

16

APIL

Country
PEGS Boston Summit
Not Confirmed
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APIL

Country
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PEGS Boston Summit
Not Confirmed

RISEDRONATE SODIUM

Brand Name : ACTONEL

Dosage Form : TABLET;ORAL

Dosage Strength : 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2007-04-16

Application Number : 20835

Regulatory Info : DISCN

Registration Country : USA

blank

17

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Risedronate Sodium 2.5-Hydrate

Brand Name : Risedronate Orifarm

Dosage Form : Film Coated Tablet

Dosage Strength : 5mg

Packaging :

Approval Date : 24-09-2010

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

blank

18

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Risedronate Sodium 2.5-Hydrate

Brand Name : Risedronate Orifarm

Dosage Form : Film Coated Tablet

Dosage Strength : 30mg

Packaging :

Approval Date : 24-09-2010

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

blank

19

PEGS Boston Summit
Not Confirmed
arrow
arrow
PEGS Boston Summit
Not Confirmed

Risedronate Sodium 2.5-Hydrate

Brand Name : Risedronate Orifarm

Dosage Form : Film Coated Tablet

Dosage Strength : 35mg

Packaging :

Approval Date : 24-09-2010

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

blank

20

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Risedronate Sodium 2.5-Hydrate

Brand Name : Risedronate Sandoz

Dosage Form : Film Coated Tablet

Dosage Strength : 35mg

Packaging :

Approval Date : 27-08-2010

Application Number : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

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