PREGABALIN
These highlights do not include all the information needed to use PREGABALIN ORAL SOLUTION safely and effectively. See full prescribing information for PREGABALIN ORAL SOLUTION. PREGABALIN Oral Solution, CV Initial U.S. Approval: 2004
Approved
Approval ID
d92c94e5-e542-4177-afa8-fa00ba17634c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 21, 2022
Manufacturers
FDA
Patrin Pharma, Inc.
DUNS: 806841677
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PREGABALIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code39328-090
Application NumberANDA212604
Product Classification
M
Marketing Category
C73584
G
Generic Name
PREGABALIN
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2022
FDA Product Classification
INGREDIENTS (8)
PREGABALINActive
Quantity: 20 mg in 1 mL
Code: 55JG375S6M
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT