NDC 68083-231

Olopatadine Hydrochloride Ophthalmic Solution

Olopatadine Hydrochloride Ophthalmic

Olopatadine Hydrochloride Ophthalmic Solution is a Ophthalmic Solution in the Human Otc Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Olopatadine Hydrochloride.

Product ID68083-231_9a4c58dc-aee6-441f-8081-608e4fd36193
NDC68083-231
Product TypeHuman Otc Drug
Proprietary NameOlopatadine Hydrochloride Ophthalmic Solution
Generic NameOlopatadine Hydrochloride Ophthalmic
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2020-05-20
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA209752
Labeler NameGland Pharma Limited
Substance NameOLOPATADINE HYDROCHLORIDE
Active Ingredient Strength2 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68083-231-01

1 BOTTLE, PLASTIC in 1 CARTON (68083-231-01) > 2.5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2020-05-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-231-01 [68083023101]

Olopatadine Hydrochloride Ophthalmic Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA209752
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-05-20

Drug Details

NDC Crossover Matching brand name "Olopatadine Hydrochloride Ophthalmic Solution" or generic name "Olopatadine Hydrochloride Ophthalmic"

NDCBrand NameGeneric Name
0363-7130Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
0363-7131Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
0536-1307Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
0536-1308Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
11673-688Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
11673-689Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic Solution
11822-9975Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
11822-9976Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
21130-105Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
43598-764Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
43598-765Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
55910-109Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
55910-137Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
63868-821Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
63868-822Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
68083-231Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
68083-477Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
70677-0122Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride Ophthalmic
69842-268CVS Eye Allergy Itch ReliefOlopatadine Hydrochloride Ophthalmic
69842-269CVS Eye Allergy Itch ReliefOlopatadine Hydrochloride Ophthalmic
43598-826Eye Allergy Itch and Redness ReliefOlopatadine Hydrochloride Ophthalmic
62011-0469Eye Allergy Itch and Redness ReliefOlopatadine Hydrochloride Ophthalmic
70000-0054Eye Allergy Itch and Redness ReliefOlopatadine Hydrochloride Ophthalmic
43598-827Eye Allergy Itch ReliefOlopatadine Hydrochloride Ophthalmic
62011-0468Eye Allergy Itch ReliefOlopatadine Hydrochloride Ophthalmic
70000-0053Eye Allergy Itch ReliefOlopatadine Hydrochloride Ophthalmic
69097-276Olopatadine HydrochlorideOlopatadine Hydrochloride Ophthalmic Solution
37808-045Once Daily ReliefOlopatadine Hydrochloride Ophthalmic Solution

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