Dorzolamide Hydrochloride-Timolol Maleate

Product NDC
0527-1763
11-digit product format
005271763
Labeler code
0527
Product ID
0527-1763_253f7644-0bcd-46ef-b70d-392f733de1cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride-Timolol Maleate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Lannett Company, Inc.
Application
ANDA201998
Marketing category
ANDA
Marketing start
2014-12-17
Marketing end
0000-00-00
Substance
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active strength
20 mg/mL; mg/mL
Pharmacologic classes
Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-1763-73005271763731 BOTTLE, DROPPER in 1 CARTON (0527-1763-73) > 10 mL in 1 BOTTLE, DROPPER2014-12-170000-00-00NoNoCurrent