Dorzolamide HCl and Timolol Maleate

Product NDC
17478-514
11-digit product format
174780514
Labeler code
17478
Product ID
17478-514_faa7101b-4b0f-4ed8-a1f5-d49599b7ba63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride and Timolol Maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA203058
Marketing category
ANDA
Marketing start
2014-09-22
Marketing end
0000-00-00
Substance
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active strength
20 mg/mL; mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-514-11174780514111 BOTTLE, DROPPER in 1 CARTON (17478-514-11) > 10 mL in 1 BOTTLE, DROPPER2014-09-220000-00-00NoNoCurrent