NDC 72689-0010

FESTAL PLUS

Ursodeoxycholic Acid, Simethicone, Pancreatin, Cellulase Ap3

FESTAL PLUS is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Oasis Trading. The primary component is Ursodiol; Pancrelipase; Dimethicone.

Product ID72689-0010_7b4ab2b8-bdfb-9635-e053-2a91aa0acb4c
NDC72689-0010
Product TypeHuman Otc Drug
Proprietary NameFESTAL PLUS
Generic NameUrsodeoxycholic Acid, Simethicone, Pancreatin, Cellulase Ap3
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-11-21
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameOASIS TRADING
Substance NameURSODIOL; PANCRELIPASE; DIMETHICONE
Active Ingredient Strength10 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 72689-0010-1

10 TABLET in 1 BLISTER PACK (72689-0010-1)
Marketing Start Date2018-11-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72689-0010-1 [72689001001]

FESTAL PLUS TABLET
Marketing Categoryunapproved drug other
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-21
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
URSODIOL10 mg/1

OpenFDA Data

SPL SET ID:7b4ab2b8-bdf9-9635-e053-2a91aa0acb4c
Manufacturer
UNII

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