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Generated: November 21, 2018

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Details for New Drug Application (NDA): 021145

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NDA 021145 describes VANIQA, which is a drug marketed by Skinmedica and is included in one NDA. It is available from one supplier. Additional details are available on the VANIQA profile page.

The generic ingredient in VANIQA is eflornithine hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eflornithine hydrochloride profile page.
Summary for 021145
Tradename:VANIQA
Applicant:Skinmedica
Ingredient:eflornithine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021145
Mechanism of ActionDecarboxylase Inhibitors
Medical Subject Heading (MeSH) Categories for 021145
Suppliers and Packaging for NDA: 021145
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANIQA eflornithine hydrochloride CREAM;TOPICAL 021145 NDA Allergan, Inc. 0023-4857 0023-4857-45 1 TUBE in 1 CARTON (0023-4857-45) > 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength13.9%
Approval Date:Jul 27, 2000TE:RLD:Yes

Expired US Patents for NDA 021145

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Skinmedica VANIQA eflornithine hydrochloride CREAM;TOPICAL 021145-001 Jul 27, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Skinmedica VANIQA eflornithine hydrochloride CREAM;TOPICAL 021145-001 Jul 27, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Skinmedica VANIQA eflornithine hydrochloride CREAM;TOPICAL 021145-001 Jul 27, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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