ACCOLATE
- Product NDC
- 49884-010
- 11-digit product format
- 498840010
- Labeler code
- 49884
- Product ID
- 49884-010_f8196ea6-8746-4266-9693-4dca9856b558
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zafirlukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Par Pharmaceutical Inc.
- Application
- NDA020547
- Marketing category
- NDA
- Marketing start
- 2015-01-09
- Marketing end
- 2019-04-30
- Substance
- ZAFIRLUKAST
- Active strength
- 10 mg/1
- Pharmacologic classes
- Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Leukotriene Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record