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Approved Drug Products containing NCGC00024928-02 listed in the FDA Orange Book. Original Data : FDA Website

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Product

NCGC00024928-02
FDA Orange Book

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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NCGC00024928-02

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 11 USDMF, 6 CEP/COS, 2 JDMF, 4 KDMF, 14 NDC API, 19 Listed Suppliers, $ API Reference Price

30 API Suppliers
11 USDMF
6 CEP/COS
2 JDMF
4 KDMF
14 NDC API
19 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

8 API Suppliers

8 API Suppliers

FINISHED DOSAGE FORMULATIONS

127 FDF Dossiers, 26 FDA Orange Book, 54 Europe, 6 Canada, 14 Australia, 9 South Africa, 18 Listed Dossiers

127 FDF Dossiers
26 FDA Orange Book
54 Europe
6 Canada
14 Australia
9 South Africa
18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - EQ 20MG BASE/10ML

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**
SOLUTION;ORAL - EQ 20MG BASE/10ML

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 4 DKSH, 1 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 5 Actylis, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 24 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 28 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 41 Direct Compression, 28 Controlled & Modified Release, 26 Granulation, 26 Thickeners and Stabilizers, 24 Disintegrants & Superdisintegrants, 21 Taste Masking, 20 Film Formers & Plasticizers, 20 Co-Processed Excipients, 18 Solubilizers, 16 Chewable & Orodispersible Aids, 16 Parenteral, 14 Lubricants & Glidants, 13 Topical, 7 Rheology Modifiers, 6 API Stability Enhancers, 5 Emulsifying Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 2 Surfactant & Foaming Agents, 1 Soft Gelatin

92 Fillers, Diluents & Binders
51 Coating Systems & Additives
41 Direct Compression
28 Controlled & Modified Release
26 Granulation
26 Thickeners and Stabilizers
24 Disintegrants & Superdisintegrants
21 Taste Masking
20 Film Formers & Plasticizers
20 Co-Processed Excipients
18 Solubilizers
16 Chewable & Orodispersible Aids
16 Parenteral
14 Lubricants & Glidants
13 Topical
7 Rheology Modifiers
6 API Stability Enhancers
5 Emulsifying Agents
5 Empty Capsules
4 Vegetarian Capsules
4 Coloring Agents
2 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 23 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
23 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 53 Finished Drug Prices

2 US Medicaid Prescriptions
53 Finished Drug Prices

MARKET PLACE

6 APIs, 9 FDF Dossiers

6 APIs
9 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 1 Others

3 EDQM
1 USP
1 Others

$ API Ref.Price (USD/KG) : 336 Xls

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26 All

01 2DR REDDYS LABS SA

02 4ACTAVIS LABS FL INC

03 2AEGIS PHARMS

04 2APOTEX

05 2ASTRAZENECA

06 2EUGIA PHARMA

07 2IVAX SUB TEVA PHARMS

08 1MAYNE PHARMA COMMRCL

09 2MYLAN

10 1PHARMACHEMIE

11 2ROXANE

12 2TEVA

13 2ZYDUS PHARMS

filter Dosage Reset all filters

26 All

01 1SOLUTION;ORAL

02 25TABLET;ORAL

filter Regulatory Info Reset all filters

26 All

01 13DISCN

02 13RX

filter Brand Name Reset all filters

26 All

01 2NOLVADEX

02 1SOLTAMOX

03 23TAMOXIFEN CITRATE

filter RLD Reset all filters

26 All

01 23No

02 3Yes

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

DR REDDYS LABS SA

CPhI Worldwide, Milan

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

Contact Supplier

Digital Content

RLD : No

TE Code : AB

TAMOXIFEN CITRATE

Brand Name : TAMOXIFEN CITRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2003-02-20

Application Number : 75797

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

Product Web Link

Digital Content

02

DR REDDYS LABS SA

CPhI Worldwide, Milan

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

Contact Supplier

Digital Content

RLD : No

TE Code : AB

TAMOXIFEN CITRATE

Brand Name : TAMOXIFEN CITRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2003-02-20

Application Number : 75797

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

Product Web Link

Digital Content

03

ACTAVIS LABS FL INC

Formnext Forum

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ACTAVIS LABS FL INC

Formnext Forum

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Digital Content

RLD : No

TE Code : AB

TAMOXIFEN CITRATE

Brand Name : TAMOXIFEN CITRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2003-02-20

Application Number : 70929

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

ACTAVIS LABS FL INC

Formnext Forum

Not Confirmed

ACTAVIS LABS FL INC

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Digital Content

RLD : No

TE Code : AB

TAMOXIFEN CITRATE

Brand Name : TAMOXIFEN CITRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2003-02-20

Application Number : 70929

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

ASTRAZENECA

Formnext Forum

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ASTRAZENECA

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Digital Content

RLD : Yes

TE Code :

TAMOXIFEN CITRATE

Brand Name : NOLVADEX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 17970

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

ASTRAZENECA

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ASTRAZENECA

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Digital Content

RLD : Yes

TE Code :

TAMOXIFEN CITRATE

Brand Name : NOLVADEX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1994-03-21

Application Number : 17970

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

MAYNE PHARMA COMMRCL

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MAYNE PHARMA COMMRCL

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Digital Content

RLD : Yes

TE Code :

TAMOXIFEN CITRATE

Brand Name : SOLTAMOX

Dosage Form : SOLUTION;ORAL

Dosage Strength : EQ 20MG BASE/10ML

Approval Date : 2005-10-29

Application Number : 21807

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

PHARMACHEMIE

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PHARMACHEMIE

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Digital Content

RLD : No

TE Code :

TAMOXIFEN CITRATE

Brand Name : TAMOXIFEN CITRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2003-03-31

Application Number : 74539

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

TEVA

Formnext Forum

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TEVA

Formnext Forum

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Digital Content

RLD : No

TE Code :

TAMOXIFEN CITRATE

Brand Name : TAMOXIFEN CITRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2003-04-28

Application Number : 74504

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

TEVA

Formnext Forum

Not Confirmed

TEVA

Formnext Forum

Not Confirmed

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Post an Enquiry

Digital Content

RLD : No

TE Code :

TAMOXIFEN CITRATE

Brand Name : TAMOXIFEN CITRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2003-04-28

Application Number : 74504

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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