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Approved Drug Products containing Micafungin listed in the FDA Orange Book. Original Data : FDA Website

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Product

Micafungin
CAS 179162-55-1
Pneumocandin M1
FDA Orange Book

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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PharmaCompass Sponsored Ads

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Micafungin

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 13 USDMF, 5 JDMF, 3 EU WC, 1 KDMF, 11 NDC API, 21 Listed Suppliers, $ API Reference Price

32 API Suppliers
13 USDMF
5 JDMF
3 EU WC
1 KDMF
11 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

55 FDF Dossiers, 26 FDA Orange Book, 8 Europe, 4 Canada, 6 South Africa, 11 Listed Dossiers

55 FDF Dossiers
26 FDA Orange Book
8 Europe
4 Canada
6 South Africa
11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INTRAVENOUS - EQ 100MG BASE/VIAL, INJECTABLE;INTRAVENOUS - EQ 50MG BASE/VIAL, SOLUTION;INTRAVENOUS - EQ 100MG BASE/100ML (EQ 1MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 150MG BASE/150ML (EQ 1MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 50MG BASE/50ML (EQ 1MG BASE/ML)

INJECTABLE;INTRAVENOUS - EQ 100MG BASE/VIAL
INJECTABLE;INTRAVENOUS - EQ 50MG BASE/VIAL
SOLUTION;INTRAVENOUS - EQ 100MG BASE/100ML (EQ 1MG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 150MG BASE/150ML (EQ 1MG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 50MG BASE/50ML (EQ 1MG BASE/ML)

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 17 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
17 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 6 Finished Drug Prices, 8 Annual Reports

2 US Medicaid Prescriptions
6 Finished Drug Prices
8 Annual Reports

MARKET PLACE

8 APIs, 1 FDF Dossiers

8 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

7 Health Canada Patents

7 Health Canada Patents

$ API Ref.Price (USD/KG) : 103,536 Xls

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26 All

01 2APOTEX

02 2ASTELLAS

03 3BAXTER HLTHCARE CORP

04 2BIOCON PHARMA

05 2ENDO OPERATIONS

06 2FRESENIUS KABI USA

07 1FUJISAWA HLTHCARE

08 2HIKMA

09 2JIANGSU HANSOH PHARM

10 2MEITHEAL

11 2TEVA PHARMS USA INC

12 2XELLIA PHARMS APS

13 2ZYDUS PHARMS

filter Dosage Reset all filters

26 All

01 1INJECTABLE; INJECTION

02 18INJECTABLE;INTRAVENOUS

03 4POWDER;INTRAVENOUS

04 3SOLUTION;INTRAVENOUS

filter Regulatory Info Reset all filters

26 All

01 4DISCN

02 21RX

03 1Blank

filter Brand Name Reset all filters

26 All

01 4MICAFUNGIN

02 3MICAFUNGIN IN SODIUM CHLORIDE 0.9%

03 16MICAFUNGIN SODIUM

04 3MYCAMINE

filter RLD Reset all filters

26 All

01 16No

02 9Yes

03 1Blank

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
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RLD : No

TE Code :

MICAFUNGIN SODIUM

Brand Name : MICAFUNGIN SODIUM

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 2020-11-05

Application Number : 208366

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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APOTEX

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APOTEX

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RLD : No

TE Code :

MICAFUNGIN SODIUM

Brand Name : MICAFUNGIN SODIUM

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : EQ 100MG BASE/VIAL

Approval Date : 2020-11-05

Application Number : 208366

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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ASTELLAS

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ASTELLAS

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RLD : Yes

TE Code : AP

MICAFUNGIN SODIUM

Brand Name : MYCAMINE

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 2005-03-16

Application Number : 21506

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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04

ASTELLAS

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ASTELLAS

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RLD : Yes

TE Code : AP

MICAFUNGIN SODIUM

Brand Name : MYCAMINE

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : EQ 100MG BASE/VIAL

Approval Date : 2006-06-27

Application Number : 21506

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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FUJISAWA HLTHCARE

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RLD :

TE Code :

MICAFUNGIN SODIUM

Brand Name : MYCAMINE

Dosage Form : INJECTABLE; INJECTION

Dosage Strength : 50MG

Approval Date :

Application Number : 21754

RX/OTC/DISCN :

RLD :

TE Code :

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FRESENIUS KABI USA

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FRESENIUS KABI USA

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RLD : No

TE Code : AP

MICAFUNGIN SODIUM

Brand Name : MICAFUNGIN SODIUM

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 2019-05-17

Application Number : 207344

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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07

FRESENIUS KABI USA

Luxepack

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FRESENIUS KABI USA

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Digital Content

RLD : No

TE Code : AP

MICAFUNGIN SODIUM

Brand Name : MICAFUNGIN SODIUM

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : EQ 100MG BASE/VIAL

Approval Date : 2019-05-17

Application Number : 207344

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Portfolio PDF

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TEVA PHARMS USA INC

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TEVA PHARMS USA INC

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RLD : Yes

TE Code :

MICAFUNGIN SODIUM

Brand Name : MICAFUNGIN

Dosage Form : POWDER;INTRAVENOUS

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 2021-07-30

Application Number : 212125

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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XELLIA PHARMS APS

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XELLIA PHARMS APS

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Digital Content

RLD : No

TE Code : AP

MICAFUNGIN SODIUM

Brand Name : MICAFUNGIN SODIUM

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 2021-06-02

Application Number : 211713

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Portfolio PDF

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10

XELLIA PHARMS APS

Luxepack

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XELLIA PHARMS APS

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Digital Content

RLD : No

TE Code : AP

MICAFUNGIN SODIUM

Brand Name : MICAFUNGIN SODIUM

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : EQ 100MG BASE/VIAL

Approval Date : 2021-06-02

Application Number : 211713

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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