Details for New Drug Application (NDA): 017962

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NDA 017962 describes PARLODEL, which is a drug marketed by Esjay Pharma 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:	Esjay Pharma
Ingredient:	bromocriptine mesylate
Patents:	0

Pharmacology for NDA: 017962

Medical Subject Heading (MeSH) Categories for 017962

Antiparkinson Agents
Dopamine Agonists
Hormone Antagonists

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:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 017962

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Esjay Pharma	PARLODEL	bromocriptine mesylate	CAPSULE;ORAL	017962-002	Mar 1, 1982	3,752,814	⤷ Subscribe
Esjay Pharma	PARLODEL	bromocriptine mesylate	TABLET;ORAL	017962-001	Approved Prior to Jan 1, 1982	3,752,888	⤷ Subscribe
Esjay Pharma	PARLODEL	bromocriptine mesylate	TABLET;ORAL	017962-001	Approved Prior to Jan 1, 1982	3,752,814	⤷ Subscribe
Esjay Pharma	PARLODEL	bromocriptine mesylate	CAPSULE;ORAL	017962-002	Mar 1, 1982	3,752,888	⤷ Subscribe
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