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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 206452


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NDA 206452 describes PREGABALIN, which is a drug marketed by 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, Anda Repository, 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 206452
Tradename:PREGABALIN
Applicant:Cadila Pharms Ltd
Ingredient:pregabalin
Patents:0
Medical Subject Heading (MeSH) Categories for 206452
Suppliers and Packaging for NDA: 206452
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREGABALIN pregabalin CAPSULE;ORAL 206452 ANDA Cadila Pharmaceuticals Limited 71209-032 71209-032-04 90 CAPSULE in 1 BOTTLE (71209-032-04)
PREGABALIN pregabalin CAPSULE;ORAL 206452 ANDA Cadila Pharmaceuticals Limited 71209-033 71209-033-04 90 CAPSULE in 1 BOTTLE (71209-033-04)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG
Approval Date:Jul 12, 2023TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG
Approval Date:Jul 12, 2023TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength75MG
Approval Date:Jul 12, 2023TE:RLD:No

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