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Last Updated: May 28, 2022

Details for New Drug Application (NDA): 017962


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NDA 017962 describes PARLODEL, which is a drug marketed by Validus Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the PARLODEL profile page.

The generic ingredient in PARLODEL is bromocriptine mesylate. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.
Summary for 017962
Tradename:PARLODEL
Applicant:Validus Pharms
Ingredient:bromocriptine mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017962
Medical Subject Heading (MeSH) Categories for 017962
Suppliers and Packaging for NDA: 017962
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PARLODEL bromocriptine mesylate CAPSULE;ORAL 017962 NDA Validus Pharmaceuticals LLC 30698-201 30698-201-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-201-01)
PARLODEL bromocriptine mesylate CAPSULE;ORAL 017962 NDA Validus Pharmaceuticals LLC 30698-201 30698-201-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-201-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Mar 1, 1982TE:ABRLD:Yes

Expired US Patents for NDA 017962

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Validus Pharms PARLODEL bromocriptine mesylate TABLET;ORAL 017962-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Validus Pharms PARLODEL bromocriptine mesylate CAPSULE;ORAL 017962-002 Mar 1, 1982 See Plans and Pricing See Plans and Pricing
Validus Pharms PARLODEL bromocriptine mesylate TABLET;ORAL 017962-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Validus Pharms PARLODEL bromocriptine mesylate CAPSULE;ORAL 017962-002 Mar 1, 1982 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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