Cardiazem

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ACTIVE PHARMA INGREDIENTS

55 API Suppliers, 21 USDMF, 8 CEP/COS, 5 JDMF, 6 EU WC, 6 KDMF, 16 NDC API, 25 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

8 Drugs in Development

8 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

391 FDF Dossiers, 234 FDA Orange Book, 40 Europe, 84 Canada, 7 South Africa, 26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 120MG, TABLET;ORAL - 30MG, TABLET;ORAL - 60MG, TABLET;ORAL - 90MG, CAPSULE, EXTENDED RELEASE;ORAL - 120MG, CAPSULE, EXTENDED RELEASE;ORAL - 180MG, CAPSULE, EXTENDED RELEASE;ORAL - 240MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG, CAPSULE, EXTENDED RELEASE;ORAL - 360MG, CAPSULE, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 120MG, CAPSULE, EXTENDED RELEASE;ORAL - 180MG, CAPSULE, EXTENDED RELEASE;ORAL - 240MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG, CAPSULE, EXTENDED RELEASE;ORAL - 360MG, CAPSULE, EXTENDED RELEASE;ORAL - 420MG, TABLET, EXTENDED RELEASE;ORAL - 120MG, TABLET, EXTENDED RELEASE;ORAL - 180MG, TABLET, EXTENDED RELEASE;ORAL - 240MG, TABLET, EXTENDED RELEASE;ORAL - 300MG, TABLET, EXTENDED RELEASE;ORAL - 360MG, TABLET, EXTENDED RELEASE;ORAL - 420MG

RELATED EXCIPIENT COMPANIES

14 Evonik, 3 Rochem International Inc, 20 SPI Pharma, 13 DKSH, 6 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 7 Kirsch Pharma, 4 ACG Worldwide, 10 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 32 BASF, 1 CD Formulation, 22 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 12 Ideal Cures, 4 Ingredion Pharma Solutions, 20 Kerry, 3 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 8 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 33 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 3 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

88 Fillers, Diluents & Binders, 75 Coating Systems & Additives, 57 Controlled & Modified Release, 45 Thickeners and Stabilizers, 40 Solubilizers, 36 Direct Compression, 33 Granulation, 31 Taste Masking, 28 Film Formers & Plasticizers, 24 Parenteral, 23 Disintegrants & Superdisintegrants, 20 Lubricants & Glidants, 19 Chewable & Orodispersible Aids, 17 Topical, 16 Co-Processed Excipients, 11 Emulsifying Agents, 11 Rheology Modifiers, 9 Empty Capsules, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

37 News #PharmaBuzz

37 News #PharmaBuzz

GLOBAL SALES INFORMATION

41 US Medicaid Prescriptions, 57 Regulatory FDF Prices, 1 Annual Reports

MARKET PLACE

13 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

25 Health Canada Patents

25 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 Others

ANALYTICAL

2 Analytical Methods

2 Analytical Methods

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USFDA APPLICATION NUMBER - 21392 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 420MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Diltiazem Hydrochloride(UNII: OLH94387TE) (Diltiazem - UNII:EE92BBP03H)	Diltiazem Hydrochloride	420mg \| 360mg \| 300mg \| 240mg \| 180mg \| 120mg

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	REMEDYREPACK INC.	AbbVie Inc.	Cipla USA, Inc.
CANDELILLA WAX(WL0328HX19)
carnauba wax(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
croscarmellose sodium(M28OL1HH48)
ethyl acrylate and methyl methacrylate copolymer (2:1; 750000 mw)(P2OM2Q86BI)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
ETHYLCELLULOSES(7Z8S9VYZ4B)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
hypromelloses(3NXW29V3WO)
ISOPROPYL ALCOHOL(ND2M416302)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)(XRK36F13ZZ)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
microcrystalline wax(XOF597Q3KY)
NONOXYNOL-100(A906T4D368)
polydextrose(VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
polyethylene glycols(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POVIDONE K30(U725QWY32X)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)
sucrose stearate(274KW0O50M)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
TRIETHYL CITRATE(8Z96QXD6UM)

Setid B4626a8d A28d 4937 Aa61 B9d958ae336c Applno 21392 Form Tablet Extended Release Oral Dosage 420mg - Drug Product Composition: Cardiazem

Cardiazem

Cardiazem

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

55 API Suppliers

21 USDMF

8 CEP/COS

5 JDMF

6 EU WC

6 KDMF

16 NDC API

25 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

8 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

391 FDF Dossiers

234 FDA Orange Book

40 Europe

84 Canada

7 South Africa

26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 120MG

TABLET;ORAL - 30MG

TABLET;ORAL - 60MG

TABLET;ORAL - 90MG

CAPSULE, EXTENDED RELEASE;ORAL - 120MG

CAPSULE, EXTENDED RELEASE;ORAL - 180MG

CAPSULE, EXTENDED RELEASE;ORAL - 240MG

CAPSULE, EXTENDED RELEASE;ORAL - 300MG

CAPSULE, EXTENDED RELEASE;ORAL - 360MG

CAPSULE, EXTENDED RELEASE;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 120MG

CAPSULE, EXTENDED RELEASE;ORAL - 180MG

CAPSULE, EXTENDED RELEASE;ORAL - 240MG

CAPSULE, EXTENDED RELEASE;ORAL - 300MG

CAPSULE, EXTENDED RELEASE;ORAL - 360MG

CAPSULE, EXTENDED RELEASE;ORAL - 420MG

TABLET, EXTENDED RELEASE;ORAL - 120MG

TABLET, EXTENDED RELEASE;ORAL - 180MG

TABLET, EXTENDED RELEASE;ORAL - 240MG

TABLET, EXTENDED RELEASE;ORAL - 300MG

TABLET, EXTENDED RELEASE;ORAL - 360MG

TABLET, EXTENDED RELEASE;ORAL - 420MG

RELATED EXCIPIENT COMPANIES

14 Evonik

3 Rochem International Inc

20 SPI Pharma

13 DKSH

6 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

2 Pfanstiehl

7 Kirsch Pharma

4 ACG Worldwide

10 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

32 BASF

1 CD Formulation

22 Corel Pharma Chem

5 DFE Pharma

1 Esteem Industries

2 Finar

11 Gangwal Chemicals

12 Ideal Cures

4 Ingredion Pharma Solutions

20 Kerry

3 Keval Exports

CAPSULE, EXTENDED RELEASE;ORAL - 120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons