You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Medtronic
AstraZeneca
McKinsey
Boehringer Ingelheim

Last Updated: August 11, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209743

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 209743 describes PREGABALIN, which is a drug marketed by Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms Co, Celltrion, Cipla, Cspc Ouyi, Dr Reddys, Hetero Labs Ltd Iii, Hikal, Invagen Pharms, MSN, Mylan, Rising, Sciegen Pharms Inc, Shuangcheng, Sun Pharm, and Teva Pharms, and is included in twenty NDAs. It is available from twenty-three suppliers. Additional details are available on the PREGABALIN profile page.

The generic ingredient in PREGABALIN is pregabalin. There are forty-one drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 209743
Tradename:PREGABALIN
Applicant:Amneal Pharms Co
Ingredient:pregabalin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 209743
Suppliers and Packaging for NDA: 209743
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREGABALIN pregabalin CAPSULE;ORAL 209743 ANDA Amneal Pharmaceuticals NY LLC 69238-1310 69238-1310-9 90 CAPSULE in 1 BOTTLE (69238-1310-9)
PREGABALIN pregabalin CAPSULE;ORAL 209743 ANDA Amneal Pharmaceuticals NY LLC 69238-1311 69238-1311-9 90 CAPSULE in 1 BOTTLE (69238-1311-9)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Jul 19, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jul 19, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Jul 19, 2019TE:ABRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Baxter
Merck
Dow
McKinsey

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.