Nisoldipine | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Nisoldipine
FDA Orange Book

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

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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Nisoldipine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

11 API Suppliers, 8 USDMF, 2 JDMF, 1 EU WC, 2 NDC API, 4 Listed Suppliers, $ API Reference Price

11 API Suppliers
8 USDMF
2 JDMF
1 EU WC
2 NDC API
4 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

19 FDF Dossiers, 16 FDA Orange Book, 1 Europe, 2 Listed Dossiers

19 FDF Dossiers
16 FDA Orange Book
1 Europe
2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 17MG, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 34MG, TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8.5MG

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 17MG
TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 34MG
TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 8.5MG

RELATED EXCIPIENT COMPANIES

2 Evonik, 2 Seqens, 3 DKSH, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 11 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 5 Gangwal Chemicals, 8 Ideal Cures Pvt Ltd, 28 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 9 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 3 Roquette, 6 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Sigachi Industries, 2 The Dow Chemical Company, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

50 Coating Systems & Additives, 37 Fillers, Diluents & Binders, 29 Controlled & Modified Release, 15 Granulation, 15 Direct Compression, 12 Lubricants & Glidants, 12 Solubilizers, 9 Film Formers & Plasticizers, 9 Co-Processed Excipients, 8 Thickeners and Stabilizers, 8 Topical, 5 Parenteral, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Taste Masking, 4 Coloring Agents, 4 Emulsifying Agents, 2 Disintegrants & Superdisintegrants, 1 Chewable & Orodispersible Aids, 1 Surfactant & Foaming Agents, 1 Rheology Modifiers

50 Coating Systems & Additives
37 Fillers, Diluents & Binders
29 Controlled & Modified Release
15 Granulation
15 Direct Compression
12 Lubricants & Glidants
12 Solubilizers
9 Film Formers & Plasticizers
9 Co-Processed Excipients
8 Thickeners and Stabilizers
8 Topical
5 Parenteral
5 Empty Capsules
4 Vegetarian Capsules
4 API Stability Enhancers
4 Taste Masking
4 Coloring Agents
4 Emulsifying Agents
2 Disintegrants & Superdisintegrants
1 Chewable & Orodispersible Aids
1 Surfactant & Foaming Agents
1 Rheology Modifiers

DIGITAL CONTENT

1 NEWS #PharmaBuzz

1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 1 Finished Drug Prices

2 US Medicaid Prescriptions
1 Finished Drug Prices

REF. STANDARDS & IMPURITIES

5 Others

5 Others

$ API Ref.Price (USD/KG) : 2,758 Xls

Filters

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filter Applicant Reset all filters

16 All

01 1AMTA

02 8COVIS

03 7MYLAN

filter Dosage Reset all filters

16 All

01 16TABLET, EXTENDED RELEASE;ORAL

filter Regulatory Info Reset all filters

16 All

01 6DISCN

02 10RX

filter Brand Name Reset all filters

16 All

01 8NISOLDIPINE

02 8SULAR

filter RLD Reset all filters

16 All

01 8No

02 8Yes

List of Suppliers

Product Main Page

01

COVIS

Antibody Engineering

Not Confirmed

COVIS

Antibody Engineering

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

NISOLDIPINE

Brand Name : SULAR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

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

Approval Date : 1995-02-02

Application Number : 20356

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

COVIS

Antibody Engineering

Not Confirmed

COVIS

Antibody Engineering

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

NISOLDIPINE

Brand Name : SULAR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

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

Approval Date : 1995-02-02

Application Number : 20356

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

COVIS

Antibody Engineering

Not Confirmed

COVIS

Antibody Engineering

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

NISOLDIPINE

Brand Name : SULAR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1995-02-02

Application Number : 20356

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

COVIS

Antibody Engineering

Not Confirmed

COVIS

Antibody Engineering

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

NISOLDIPINE

Brand Name : SULAR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1995-02-02

Application Number : 20356

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

COVIS

Antibody Engineering

Not Confirmed

COVIS

Antibody Engineering

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

NISOLDIPINE

Brand Name : SULAR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 34MG

Approval Date : 2008-01-02

Application Number : 20356

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

COVIS

Antibody Engineering

Not Confirmed

COVIS

Antibody Engineering

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

NISOLDIPINE

Brand Name : SULAR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2008-01-02

Application Number : 20356

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

COVIS

Antibody Engineering

Not Confirmed

COVIS

Antibody Engineering

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

NISOLDIPINE

Brand Name : SULAR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 17MG

Approval Date : 2008-01-02

Application Number : 20356

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

COVIS

Antibody Engineering

Not Confirmed

COVIS

Antibody Engineering

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

NISOLDIPINE

Brand Name : SULAR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 8.5MG

Approval Date : 2008-01-02

Application Number : 20356

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

MYLAN

Antibody Engineering

Not Confirmed

MYLAN

Antibody Engineering

Not Confirmed

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Digital Content

RLD : No

TE Code :

NISOLDIPINE

Brand Name : NISOLDIPINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 20MG

Approval Date : 2008-07-25

Application Number : 79051

RX/OTC/DISCN : RX

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

MYLAN

Antibody Engineering

Not Confirmed

MYLAN

Antibody Engineering

Not Confirmed

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Digital Content

RLD : No

TE Code :

NISOLDIPINE

Brand Name : NISOLDIPINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 30MG

Approval Date : 2008-07-25

Application Number : 79051

RX/OTC/DISCN : RX

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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