NDC 0536-1222

Ketotifen Fumarate

Ketotifen Fumarate

Ketotifen Fumarate is a Ophthalmic Solution in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories. The primary component is Ketotifen Fumarate.

Product ID0536-1222_812888bd-5b50-8ece-7a66-83f46279da3e
NDC0536-1222
Product TypeHuman Otc Drug
Proprietary NameKetotifen Fumarate
Generic NameKetotifen Fumarate
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2019-04-24
Marketing CategoryANDA / ANDA
Application NumberANDA077354
Labeler NameRugby Laboratories
Substance NameKETOTIFEN FUMARATE
Active Ingredient Strength0 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0536-1222-40

1 BOTTLE, PLASTIC in 1 CARTON (0536-1222-40) > 5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2019-04-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-1222-40 [00536122240]

Ketotifen Fumarate SOLUTION
Marketing CategoryANDA
Application NumberANDA077354
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-04-24

Drug Details

Active Ingredients

IngredientStrength
KETOTIFEN FUMARATE.25 mg/mL

OpenFDA Data

SPL SET ID:f1098690-09fa-814b-8caa-dc38042570e4
Manufacturer
UNII