NDC 60505-6215

Ketotifen Fumarate

Ketotifen Fumarate

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

Product ID60505-6215_002c310b-306d-2ebf-4f37-bf465c7a2834
NDC60505-6215
Product TypeHuman Otc Drug
Proprietary NameKetotifen Fumarate
Generic NameKetotifen Fumarate
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2019-08-02
Marketing CategoryANDA / ANDA
Application NumberANDA077354
Labeler NameApotex Corp.
Substance NameKETOTIFEN FUMARATE
Active Ingredient Strength0 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 60505-6215-1

1 BOTTLE, PLASTIC in 1 CARTON (60505-6215-1) > 5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2019-08-02
Marketing End Date2022-10-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-6215-1 [60505621501]

Ketotifen Fumarate SOLUTION
Marketing CategoryANDA
Application NumberANDA077354
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-08-02

Drug Details

Active Ingredients

IngredientStrength
KETOTIFEN FUMARATE.25 mg/mL

OpenFDA Data

SPL SET ID:af5a9e20-2a5d-4934-544d-b01f71ff8155
Manufacturer
UNII

NDC Crossover Matching brand name "Ketotifen Fumarate" or generic name "Ketotifen Fumarate"

NDCBrand NameGeneric Name
0179-8601Ketotifen FumarateKetotifen Fumarate
0363-9060Ketotifen FumarateKetotifen Fumarate
0536-1222Ketotifen FumarateKetotifen Fumarate
0536-1252Ketotifen FumarateKetotifen Fumarate
17478-717Ketotifen FumarateKetotifen Fumarate
69842-600Ketotifen FumarateKetotifen Fumarate
69842-601Ketotifen FumarateKetotifen Fumarate
70518-1142Ketotifen FumarateKetotifen Fumarate
71205-115Ketotifen FumarateKetotifen Fumarate
58790-008Ketotifen FumarateKetotifen Fumarate
59779-627Ketotifen FumarateKetotifen Fumarate
59779-330Ketotifen FumarateKetotifen Fumarate
70677-0052Ketotifen FumarateKetotifen Fumarate
62011-0379Ketotifen FumarateKetotifen Fumarate
60505-6215Ketotifen FumarateKetotifen Fumarate
46122-304Ketotifen FumarateKetotifen Fumarate
46122-634Ketotifen FumarateKetotifen Fumarate
72189-114KETOTIFEN FUMARATEKETOTIFEN FUMARATE
70518-2867Ketotifen FumarateKetotifen Fumarate
24208-601AlawayKetotifen Fumarate
24208-600Alaway Preservative Freeketotifen fumarate
11822-5533Eye Itch ReleifKetotifen Fumarate
0363-0038Eye Itch Reliefketotifen fumarate
0363-0610EYE ITCH RELIEFKetotifen Fumarate
0536-1096Eye Itch ReliefKetotifen Fumarate
11673-064Eye Itch Reliefketotifen fumarate
11822-4201eye itch reliefketotifen fumarate
11822-4202eye itch reliefketotifen fumarate
21130-601Eye Itch ReliefKetotifen Fumarate
11716-1163LEADER EYE ITCH RELIEF DROPSKETOTIFEN FUMARATE
0065-4011Zaditorketotifen fumarate
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