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GABAPENTIN

These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993

Approved
Approval ID

b86c81d9-9a4a-4847-be18-520e5cc5dc4b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 27, 2024

Manufacturers
FDA

Camber Pharmaceuticals, Inc.

DUNS: 826774775

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

GABAPENTIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code31722-069
Application NumberANDA217682
Product Classification
M
Marketing Category
C73584
G
Generic Name
GABAPENTIN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2024
FDA Product Classification

INGREDIENTS (10)

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ANISEInactive
Code: 21C2F5E8RE
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
GABAPENTINActive
Quantity: 250 mg in 5 mL
Code: 6CW7F3G59X
Classification: ACTIB

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GABAPENTIN - FDA Drug Approval Details