Manufacturing Establishments5
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Plantex Ltd.
Amryt Pharmaceuticals Designated Activity Company
600023907
Assia Chemical Industries Ltd - Teva Tech Site
Amryt Pharmaceuticals Designated Activity Company
649323474
Almac Pharma Services Limited
Amryt Pharmaceuticals Designated Activity Company
233170864
MW ENCAP LIMITED
Amryt Pharmaceuticals Designated Activity Company
578075491
Lyophilization Services of New England, Inc. (LSNE)
Amryt Pharmaceuticals Designated Activity Company
028180765
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mycapssa
Product Details
NDC Product Code
69880-120Application Number
NDA208232Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 15, 2023OctreotideActive
Code: RWM8CCW8GPClass: ACTIBQuantity: 20 mg in 1 1
POVIDONE K12Inactive
Code: 333AG72FWJClass: IACT
sodium caprylateInactive
Code: 9XTM81VK2BClass: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9OClass: IACT
TRICAPRILINInactive
Code: 6P92858988Class: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
glyceryl monocaprylateInactive
Code: TM2TZD4G4AClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT