FDA APPLICATION 77154 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Mallinckrodt Pharmaceuticals

TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Your reliable CDMO partner - agile, scalable, top-quality Small Molecule API & HPAPI solutions from concept to market

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pharmacompass-1-m-2025-11-24

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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pharmacompass-2-m-2025-11-03

Mallinckrodt Pharmaceuticals

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 412 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
412 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

241 All APIs, 196 USDMF, 19 CEP/COS, 8 JDMF, 16 KDMF, 99 NDC API, 1 VMF, 37 Listed APIs

241 All APIs
196 USDMF
19 CEP/COS
8 JDMF
16 KDMF
99 NDC API
1 VMF
37 Listed APIs

DEVELOPMENTS

174 Drugs in Development

174 Drugs in Development

FINISHED DOSAGE FORMULATIONS

443 FDF Dossiers, 280 FDA Orange Book, 53 Europe, 2 Canada, 28 South Africa, 80 Listed Dossiers

443 FDF Dossiers
280 FDA Orange Book
53 Europe
2 Canada
28 South Africa
80 Listed Dossiers

EXCIPIENTS

4 All Excipients, 2 USDMF, 1 CEP/COS, 1 NDC API

4 All Excipients
2 USDMF
1 CEP/COS
1 NDC API

REF. STANDARDS & IMPURITIES

73 Others

73 Others

INSPECTIONS & REGISTRATIONS

35 FDA, 5 EDQM, 6 GDUFA

35 FDA
5 EDQM
6 GDUFA

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filter Applicant Reset all filters

7 All

01 7SPECGX LLC

filter Dosage Reset all filters

7 All

01 7FILM, EXTENDED RELEASE;TRANSDERMAL

filter Regulatory Info Reset all filters

7 All

01 7RX

filter Brand Name Reset all filters

7 All

01 1FENTANYL-100

02 1FENTANYL-12

03 1FENTANYL-25

04 1FENTANYL-37

05 1FENTANYL-50

06 1FENTANYL-62

07 1FENTANYL-75

filter RLD Reset all filters

7 All

01 7No

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01

Brand Name : FENTANYL-50

BOS Manchester

Not Confirmed

Brand Name : FENTANYL-50

BOS Manchester

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

Mallinckrodt Pharmaceuticals

Dosage Form : FILM, EXTENDED RELEASE; TRANSD...

Proprietary Name : FENTANYL-50

Dosage Strength : 50MCG/HR

Approval Date : 2011-02-09

Application Number : 77154

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
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Place

02

Brand Name : FENTANYL-62

BOS Manchester

Not Confirmed

Brand Name : FENTANYL-62

BOS Manchester

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

Mallinckrodt Pharmaceuticals

Dosage Form : FILM, EXTENDED RELEASE; TRANSD...

Proprietary Name : FENTANYL-62

Dosage Strength : 62.5MCG/HR

Approval Date : 2020-01-14

Application Number : 77154

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
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Stock Recap
#PipelineProspector

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Place

03

Brand Name : FENTANYL-12

BOS Manchester

Not Confirmed

Brand Name : FENTANYL-12

BOS Manchester

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

Mallinckrodt Pharmaceuticals

Dosage Form : FILM, EXTENDED RELEASE; TRANSD...

Proprietary Name : FENTANYL-12

Dosage Strength : 12.5MCG/HR

Approval Date : 2015-06-11

Application Number : 77154

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
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Place

04

Brand Name : FENTANYL-75

BOS Manchester

Not Confirmed

Brand Name : FENTANYL-75

BOS Manchester

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

Mallinckrodt Pharmaceuticals

Dosage Form : FILM, EXTENDED RELEASE; TRANSD...

Proprietary Name : FENTANYL-75

Dosage Strength : 75MCG/HR

Approval Date : 2011-02-09

Application Number : 77154

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
Web Link

Stock Recap
#PipelineProspector

Market
Place

05

Brand Name : FENTANYL-25

BOS Manchester

Not Confirmed

Brand Name : FENTANYL-25

BOS Manchester

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

Mallinckrodt Pharmaceuticals

Dosage Form : FILM, EXTENDED RELEASE; TRANSD...

Proprietary Name : FENTANYL-25

Dosage Strength : 25MCG/HR

Approval Date : 2011-02-09

Application Number : 77154

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
Web Link

Stock Recap
#PipelineProspector

Market
Place

06

Brand Name : FENTANYL-37

BOS Manchester

Not Confirmed

Brand Name : FENTANYL-37

BOS Manchester

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

Mallinckrodt Pharmaceuticals

Dosage Form : FILM, EXTENDED RELEASE; TRANSD...

Proprietary Name : FENTANYL-37

Dosage Strength : 37.5MCG/HR

Approval Date : 2020-01-14

Application Number : 77154

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
Web Link

Stock Recap
#PipelineProspector

Market
Place

07

Brand Name : FENTANYL-100

BOS Manchester

Not Confirmed

Brand Name : FENTANYL-100

BOS Manchester

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

RLD : No

TE Code : AB

Mallinckrodt Pharmaceuticals

Dosage Form : FILM, EXTENDED RELEASE; TRANSD...

Proprietary Name : FENTANYL-100

Dosage Strength : 100MCG/HR

Approval Date : 2011-02-09

Application Number : 77154

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Stock Recap
#PipelineProspector

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