Details for New Drug Application (NDA): 017962

✉ Email this page to a colleague

NDA 017962 describes PARLODEL, which is a drug marketed by Ss 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:	Ss 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RX	Dosage:	CAPSULE;ORAL			Strength	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ss Pharma	PARLODEL	bromocriptine mesylate	TABLET;ORAL	017962-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Ss Pharma	PARLODEL	bromocriptine mesylate	CAPSULE;ORAL	017962-002	Mar 1, 1982	⤷ Sign Up	⤷ Sign Up
Ss Pharma	PARLODEL	bromocriptine mesylate	TABLET;ORAL	017962-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Ss Pharma	PARLODEL	bromocriptine mesylate	CAPSULE;ORAL	017962-002	Mar 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.