Clarithromycin

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ACTIVE PHARMA INGREDIENTS

116 API Suppliers, 23 USDMF, 20 CEP/COS, 16 JDMF, 3 EU WC, 57 KDMF, 12 NDC API, 37 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

99 Drugs in Development

99 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

550 FDF Dossiers, 50 FDA Orange Book, 269 Europe, 24 Canada, 8 Australia, 39 South Africa, 160 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML, FOR SUSPENSION;ORAL - 250MG/5ML, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 2 Rochem International Inc, 9 SPI Pharma, 15 DKSH, 1 Pharm-RX Chemical, 4 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 7 Kirsch Pharma, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 1 Avesta Pharma, 28 BASF, 3 CD Formulation, 2 Clariant, 14 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 10 Ideal Cures, 4 Ingredion Pharma Solutions, 22 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 1 Lubrizol Life Science Health, 15 Microlex e.U, 3 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 25 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

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70 Coating Systems & Additives, 69 Fillers, Diluents & Binders, 40 Thickeners and Stabilizers, 38 Solubilizers, 36 Controlled & Modified Release, 30 Topical, 29 Disintegrants & Superdisintegrants, 28 Granulation, 25 Direct Compression, 25 Lubricants & Glidants, 24 Parenteral, 21 Film Formers & Plasticizers, 15 Taste Masking, 15 Emulsifying Agents, 13 Co-Processed Excipients, 10 Rheology Modifiers, 10 Chewable & Orodispersible Aids, 9 Surfactant & Foaming Agents, 8 API Stability Enhancers, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules

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USFDA APPLICATION NUMBER - 50698 / DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLARITHROMYCIN(UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)	CLARITHROMYCIN	250mg in 5 \| 125mg in 5 \| 500mg \| 500mg \| 250mg

Inactive Ingredients

Ingredient Name	Zydus Pharmaceuticals USA Inc	AbbVie Inc.	A-S Medication Solutions
CARBOMER 1342(809Y72KV36)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(809Y72KV36)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(HHT01ZNK31)
CASTOR OIL(D5340Y2I9G)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
GLYCERYL MONOSTEARATE(230OU9XXE4)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(G4U024CQK6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MALTODEXTRIN(7CVR7L4A2D)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
POLOXAMER 188(LQA7B6G8JG)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POTASSIUM SORBATE(1VPU26JZZ4)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SILICON DIOXIDE(ETJ7Z6XBU4)
SORBIC ACID(X045WJ989B)
SORBITAN MONOOLEATE(06XEA2VD56)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)
VANILLIN(CHI530446X)
XANTHAN GUM(TTV12P4NEE)

Setid Aa44552c 3cfe 4111 8aa5 4251aeed9be9 Applno 50698 Form For Suspension Oral Dosage 250mg 5ml - Drug Product Composition: Clarithromycin

Clarithromycin

Clarithromycin

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ACTIVE PHARMA INGREDIENTS

116 API Suppliers

23 USDMF

20 CEP/COS

16 JDMF

3 EU WC

57 KDMF

12 NDC API

37 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

99 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

550 FDF Dossiers

50 FDA Orange Book

269 Europe

24 Canada

8 Australia

39 South Africa

160 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG **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**

FOR SUSPENSION;ORAL - 125MG/5ML

FOR SUSPENSION;ORAL - 250MG/5ML

CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **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**

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

2 Evonik

2 Rochem International Inc

9 SPI Pharma

15 DKSH

1 Pharm-RX Chemical

4 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

1 Pfanstiehl

7 Kirsch Pharma

1 ACG Worldwide

9 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

1 Avesta Pharma

28 BASF

3 CD Formulation

2 Clariant

14 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

2 Finar

13 Gangwal Chemicals

10 Ideal Cures

4 Ingredion Pharma Solutions

22 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

1 Lubrizol Life Science Health

15 Microlex e.U

3 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

5 Pluviaendo

4 Prachin Chemical

TABLET;ORAL - 250MG 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

CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG 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

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons