NDC 69918-601

Timoptic in Ocudose

Timolol Maleate

Timoptic in Ocudose is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Amring Pharmaceuticals Inc.. The primary component is Timolol Maleate.

Product ID69918-601_1a4d5b53-65eb-4b2d-9ded-526f8ad9b51d
NDC69918-601
Product TypeHuman Prescription Drug
Proprietary NameTimoptic in Ocudose
Generic NameTimolol Maleate
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2022-02-26
Marketing CategoryANDA /
Application NumberANDA212592
Labeler NameAmring Pharmaceuticals Inc.
Substance NameTIMOLOL MALEATE
Active Ingredient Strength5 mg/mL
Pharm ClassesAdrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 69918-601-60

60 POUCH in 1 CARTON (69918-601-60) > 10 CONTAINER in 1 POUCH > .3 mL in 1 CONTAINER
Marketing Start Date2022-02-26
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Timoptic in Ocudose" or generic name "Timolol Maleate"

NDCBrand NameGeneric Name
0187-1496Timoptic in OcudoseTimolol Maleate
0187-1498Timoptic in OcudoseTimolol Maleate
24208-498Timoptic in OcudoseTimolol Maleate
24208-499Timoptic in OcudoseTimolol Maleate
24208-004IstalolTimolol Maleate
0378-0055Timolol Maleatetimolol maleate
0378-0221Timolol Maleatetimolol maleate
0378-0715Timolol Maleatetimolol maleate
13811-618Timolol MaleateTimolol Maleate
13811-619Timolol MaleateTimolol Maleate
13811-620Timolol MaleateTimolol Maleate
17478-288Timolol MaleateTimolol Maleate
17478-289Timolol MaleateTimolol Maleate
24208-496Timolol MaleateTimolol Maleate
24208-812TimopticTimolol Maleate

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.