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Details for New Drug Application (NDA): 203983

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NDA 203983 describes FELODIPINE, which is a drug marketed by Sun Pharm Inds Ltd, Vintage Pharms Llc, Aurobindo Pharma Ltd, Orchid Hlthcare, Mylan, Heritage Pharms Inc, Glenmark Generics, Torrent Pharms Ltd, Jubilant Generics, Wockhardt Ltd, and Sun Pharm Inds, and is included in eleven NDAs. It is available from twenty-one suppliers. Additional details are available on the FELODIPINE profile page.

The generic ingredient in FELODIPINE is felodipine. There are seventeen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the felodipine profile page.

Summary for NDA: 203983

Tradename:
FELODIPINE
Applicant:
Jubilant Generics
Ingredient:
felodipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203983

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 203983

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FELODIPINE
felodipine
TABLET, EXTENDED RELEASE;ORAL 203983 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-369 59746-369-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59746-369-01)
FELODIPINE
felodipine
TABLET, EXTENDED RELEASE;ORAL 203983 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-369 59746-369-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59746-369-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG
Approval Date:Aug 19, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Aug 19, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Aug 19, 2016TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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