Amantadine Hydrochloride

Product NDC
0591-4930
11-digit product format
005914930
Labeler code
0591
Product ID
0591-4930_4c45e77a-6267-480a-8d4e-4dc8e919329e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA208107
Marketing category
ANDA
Marketing start
2017-01-25
Marketing end
2021-01-31
Substance
AMANTADINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record