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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 209357


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NDA 209357 describes PREGABALIN, which is a drug marketed by ACI, Actavis Elizabeth, Adaptis, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Changzhou Pharm, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Eskayef, Hetero Labs Ltd Iii, Invagen Pharms, Lupin Ltd, MSN, Mylan, Prinston Inc, Renata, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Teva Pharms, Yiling, Zydus Pharms, Patrin, Alvogen, Epic Pharma Llc, and Rubicon, and is included in forty-four NDAs. It is available from forty-nine 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. Fifty-one suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 209357
Tradename:PREGABALIN
Applicant:Msn
Ingredient:pregabalin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 209357
Suppliers and Packaging for NDA: 209357
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREGABALIN pregabalin CAPSULE;ORAL 209357 ANDA A-S Medication Solutions 50090-5071 50090-5071-0 90 CAPSULE in 1 BOTTLE (50090-5071-0)
PREGABALIN pregabalin CAPSULE;ORAL 209357 ANDA A-S Medication Solutions 50090-6503 50090-6503-0 60 CAPSULE in 1 BOTTLE (50090-6503-0)

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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