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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211384


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NDA 211384 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-two 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-one suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 211384
Tradename:PREGABALIN
Applicant:Invagen Pharms
Ingredient:pregabalin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 211384
Suppliers and Packaging for NDA: 211384
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREGABALIN pregabalin CAPSULE;ORAL 211384 ANDA Cipla USA, Inc. 69097-954 69097-954-05 90 CAPSULE in 1 BOTTLE (69097-954-05)
PREGABALIN pregabalin CAPSULE;ORAL 211384 ANDA Cipla USA, Inc. 69097-954 69097-954-12 500 CAPSULE in 1 BOTTLE (69097-954-12)

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

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