Montelukast Sodium

Product NDC
70518-0805
11-digit product format
705180805
Labeler code
70518
Product ID
70518-0805_8ecbabf8-6cc4-11c5-e053-2a95a90a8c59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091576
Marketing category
ANDA
Marketing start
2017-10-26
Marketing end
0000-00-00
Substance
MONTELUKAST SODIUM
Active strength
10 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record