SERTRALINE - 76282-212-05 - (Sertraline)

Alphabetical Index


Drug Information of SERTRALINE

Product NDC: 76282-212
Proprietary Name: SERTRALINE
Non Proprietary Name: Sertraline
Active Ingredient(s): 25    mg/1 & nbsp;   Sertraline
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of SERTRALINE

Product NDC: 76282-212
Labeler Name: Exelan Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA077397
Marketing Category: ANDA
Start Marketing Date: 20120820

Package Information of SERTRALINE

Package NDC: 76282-212-05
Package Description: 500 TABLET, FILM COATED in 1 BOTTLE (76282-212-05)

NDC Information of SERTRALINE

NDC Code 76282-212-05
Proprietary Name SERTRALINE
Package Description 500 TABLET, FILM COATED in 1 BOTTLE (76282-212-05)
Product NDC 76282-212
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Sertraline
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20120820
Marketing Category Name ANDA
Labeler Name Exelan Pharmaceuticals, Inc.
Substance Name SERTRALINE HYDROCHLORIDE
Strength Number 25
Strength Unit mg/1
Pharmaceutical Classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

Complete Information of SERTRALINE


General Information