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Last Updated: August 9, 2020

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Details for New Drug Application (NDA): 091224

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NDA 091224 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-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. Thirty-two suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 091224
Tradename:PREGABALIN
Applicant:Teva Pharms
Ingredient:pregabalin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 091224
Suppliers and Packaging for NDA: 091224
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREGABALIN pregabalin CAPSULE;ORAL 091224 ANDA Teva Pharmaceuticals USA, Inc. 0093-7621 0093-7621-98 90 CAPSULE in 1 BOTTLE (0093-7621-98)
PREGABALIN pregabalin CAPSULE;ORAL 091224 ANDA Teva Pharmaceuticals USA, Inc. 0093-7624 0093-7624-98 90 CAPSULE in 1 BOTTLE (0093-7624-98)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Jul 19, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jul 19, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Jul 19, 2019TE:ABRLD:No

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