Fluoxetine.HCl

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ACTIVE PHARMA INGREDIENTS

51 API Suppliers, 26 USDMF, 16 CEP/COS, 3 EU WC, 28 KDMF, 19 NDC API, 28 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

7 API Suppliers

7 API Suppliers

FINISHED DOSAGE FORMULATIONS

462 FDF Dossiers, 159 FDA Orange Book, 168 Europe, 45 Canada, 12 Australia, 22 South Africa, 56 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 10MG BASE, CAPSULE;ORAL - EQ 20MG BASE, CAPSULE;ORAL - EQ 40MG BASE, TABLET;ORAL - EQ 60MG BASE, CAPSULE, DELAYED REL PELLETS;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Evonik, 2 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 9 DKSH, 2 Jai Radhe Sales, 8 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 32 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 33 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 22 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

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USFDA APPLICATION NUMBER - 21235 / DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Fluoxetine hydrochloride(UNII: I9W7N6B1KJ) (Fluoxetine - UNII:01K63SUP8D)	Fluoxetine	90mg

Inactive Ingredients

Ingredient Name	Eli Lilly and Company
D&C Yellow No. 10(35SW5USQ3G)
FD&C Blue No. 2(L06K8R7DQK)
FERROSOFERRIC OXIDE(XM0M87F357)
Gelatin(2G86QN327L)
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)(24P2YXD2PW)
Hypromelloses(3NXW29V3WO)
Sodium lauryl sulfate(368GB5141J)
Sucrose(C151H8M554)
Talc(7SEV7J4R1U)
Titanium dioxide(15FIX9V2JP)
Triethyl citrate(8Z96QXD6UM)

Drug Product Composition: Fluoxetine.HCl

Fluoxetine.HCl

Fluoxetine.HCl

ACCESS ALL DATA

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

51 API Suppliers

26 USDMF

16 CEP/COS

3 EU WC

28 KDMF

19 NDC API

28 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

INTERMEDIATES

7 API Suppliers

FINISHED DOSAGE FORMULATIONS

462 FDF Dossiers

159 FDA Orange Book

168 Europe

45 Canada

12 Australia

22 South Africa

56 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 10MG BASE

CAPSULE;ORAL - EQ 20MG BASE

CAPSULE;ORAL - EQ 40MG BASE

TABLET;ORAL - EQ 60MG BASE

CAPSULE, DELAYED REL PELLETS;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

RELATED EXCIPIENT COMPANIES

1 Evonik

2 Rochem International Inc

17 SPI Pharma

2 Seqens

9 DKSH

2 Jai Radhe Sales

8 Boai NKY Pharmaceuticals Ltd

13 Gangwal Healthcare

9 Nanjing Well Pharmaceutical

2 Pfanstiehl

4 ACG Worldwide

8 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

32 BASF

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

2 Finar

13 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

33 Kerry

4 Kima Chemical

6 Lonza Capsugel

20 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

4 Novo Excipients

4 Pharmatrans-Sanaq

8 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

22 Roquette

16 Seppic

7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

12 Sigachi Industries

3 The Dow Chemical Company

CAPSULE, DELAYED REL PELLETS;ORAL - EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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

TABLET;ORAL - EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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