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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 211685


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NDA 211685 describes PREGABALIN, which is a drug marketed by ACI, Acme Labs, 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, Hetero Labs Ltd Iii, Invagen Pharms, Lupin Ltd, MSN, Norvium Bioscience, Prinston Inc, Rising, Rk Pharma, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Teva Pharms, Yiling, Zydus Pharms, Patrin, Alvogen, Epic Pharma Llc, and Rubicon, and is included in forty-five NDAs. It is available from fifty-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. Fifty-six suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 211685
Tradename:PREGABALIN
Applicant:Apotex
Ingredient:pregabalin
Patents:0
Medical Subject Heading (MeSH) Categories for 211685
Suppliers and Packaging for NDA: 211685
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREGABALIN pregabalin CAPSULE;ORAL 211685 ANDA A-S Medication Solutions 50090-6477 50090-6477-0 90 CAPSULE in 1 BOTTLE (50090-6477-0)
PREGABALIN pregabalin CAPSULE;ORAL 211685 ANDA ApotexCorp 60505-3793 60505-3793-9 90 CAPSULE in 1 BOTTLE (60505-3793-9)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Jul 7, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jul 7, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Jul 7, 2021TE:ABRLD:No

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