NDC 69880-120

Mycapssa

Octreotide

Mycapssa is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Amryt Pharmaceuticals Designated Activity Company. The primary component is Octreotide.

Product ID69880-120_55f04a73-a366-4c65-9ed5-c3051668fa19
NDC69880-120
Product TypeHuman Prescription Drug
Proprietary NameMycapssa
Generic NameOctreotide
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2020-07-06
Marketing CategoryNDA / NDA
Application NumberNDA208232
Labeler NameAmryt Pharmaceuticals Designated Activity Company
Substance NameOCTREOTIDE
Active Ingredient Strength20 mg/1
Pharm ClassesSomatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 69880-120-28

4 BLISTER PACK in 1 DOSE PACK (69880-120-28) > 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
Marketing Start Date2020-07-06
NDC Exclude FlagN
Sample Package?N

Drug Details


Trademark Results [Mycapssa]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MYCAPSSA
MYCAPSSA
86041709 4998596 Live/Registered
GENENTECH, INC.
2013-08-19

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