Fluocinolone Acetonide Oil, 0.01% (Ear Drops)

Product NDC
72641-002
11-digit product format
726410002
Labeler code
72641
Product ID
72641-002_f3d208ca-3397-49d4-860a-772d5bb0695c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinolone Acetonide Oil, 0.01% (Ear Drops)
Dosage form
OIL
Route
AURICULAR (OTIC)
Labeler
Tasman Pharma Inc.
Application
ANDA213264
Marketing category
ANDA
Marketing start
2021-02-05
Marketing end
0000-00-00
Substance
FLUOCINOLONE ACETONIDE
Active strength
0 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72641-002-20726410002201 BOTTLE, DROPPER in 1 CARTON (72641-002-20) > 20 mL in 1 BOTTLE, DROPPER2021-02-050000-00-00NoNoCurrent