Lovastatin

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ACTIVE PHARMA INGREDIENTS

47 API Suppliers, 30 USDMF, 12 CEP/COS, 1 JDMF, 4 EU WC, 2 KDMF, 9 NDC API, 11 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

97 FDF Dossiers, 37 FDA Orange Book, 48 Europe, 4 Canada, 2 South Africa, 6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 20MG, TABLET, EXTENDED RELEASE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 60MG

RELATED EXCIPIENT COMPANIES

1 Evonik, 4 SPI Pharma, 6 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 5 Kirsch Pharma, 1 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 29 BASF, 2 CD Formulation, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 10 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 2 Nanjing Bold Chemical, 2 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, 19 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

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USFDA APPLICATION NUMBER - 19643 / DOSAGE - TABLET;ORAL - 20MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
lovastatin(UNII: 9LHU78OQFD) (lovastatin - UNII:9LHU78OQFD)	lovastatin	40mg \| 20mg

Inactive Ingredients

Ingredient Name	Merck Sharp & Dohme Corp.
ALUMINUM OXIDE(LMI26O6933)
BUTYLATED HYDROXYANISOLE(REK4960K2U)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 2(L06K8R7DQK)
lactose, unspecified form(J2B2A4N98G)
magnesium stearate(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
STARCH, CORN(O8232NY3SJ)

Setid 520428f1 2cd5 447f 8782 C8505ce65b72 Applno 19643 Form Tablet Oral Dosage 20mg - Drug Product Composition: Lovastatin

Lovastatin

Lovastatin

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

47 API Suppliers

30 USDMF

12 CEP/COS

1 JDMF

4 EU WC

2 KDMF

9 NDC API

11 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

97 FDF Dossiers

37 FDA Orange Book

48 Europe

4 Canada

2 South Africa

6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

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

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

TABLET, EXTENDED RELEASE;ORAL - 20MG

TABLET, EXTENDED RELEASE;ORAL - 40MG

TABLET, EXTENDED RELEASE;ORAL - 60MG

RELATED EXCIPIENT COMPANIES

1 Evonik

4 SPI Pharma

6 DKSH

1 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

1 Pfanstiehl

5 Kirsch Pharma

1 ACG Worldwide

8 Actylis

1 Aeon Procare

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

29 BASF

2 CD Formulation

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

2 Finar

10 Gangwal Chemicals

4 Ideal Cures

3 Ingredion Pharma Solutions

24 Kerry

2 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

14 Microlex e.U

2 Nanjing Bold Chemical

2 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

19 Roquette

13 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

3 Silverline Chemicals

2 The Dow Chemical Company

1 Valens Pharmachem

3 Vasa Pharmachem

1 Vertellus

EXCIPIENTS BY APPLICATIONS

51 Fillers, Diluents & Binders

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

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

TABLET;ORAL - 40MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons