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Last Updated: July 24, 2024

Details for New Drug Application (NDA): 214322

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NDA 214322 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 fifty 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-two suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 214322
Applicant:Changzhou Pharm
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 214322
Suppliers and Packaging for NDA: 214322
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREGABALIN pregabalin CAPSULE;ORAL 214322 ANDA Tris Pharma Inc 27808-235 27808-235-01 90 CAPSULE in 1 BOTTLE (27808-235-01)
PREGABALIN pregabalin CAPSULE;ORAL 214322 ANDA Tris Pharma Inc 27808-236 27808-236-01 90 CAPSULE in 1 BOTTLE (27808-236-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jul 15, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Jul 15, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jul 15, 2021TE:ABRLD:No

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