Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210721
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE;ORAL Prescription AB1 No No
CYCLOSPORINE CYCLOSPORINE 50MG CAPSULE;ORAL Prescription AB1 No No
CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE;ORAL Prescription AB1 No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/10/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

CYCLOSPORINE

CAPSULE;ORAL; 25MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE;ORAL Prescription No AB1 210721 APOTEX
CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE;ORAL Prescription No AB1 065110 IVAX SUB TEVA PHARMS
CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE;ORAL Prescription No AB1 065044 MAYNE PHARMA
CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE;ORAL Prescription No AB1 065017 SANDOZ
GENGRAF CYCLOSPORINE 25MG CAPSULE;ORAL Prescription No AB1 065003 ABBVIE
NEORAL CYCLOSPORINE 25MG CAPSULE;ORAL Prescription Yes AB1 050715 NOVARTIS

CAPSULE;ORAL; 50MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOSPORINE CYCLOSPORINE 50MG CAPSULE;ORAL Prescription No AB1 210721 APOTEX
CYCLOSPORINE CYCLOSPORINE 50MG CAPSULE;ORAL Prescription No AB1 065110 IVAX SUB TEVA PHARMS

CAPSULE;ORAL; 100MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE;ORAL Prescription No AB1 210721 APOTEX
CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE;ORAL Prescription No AB1 065110 IVAX SUB TEVA PHARMS
CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE;ORAL Prescription No AB1 065044 MAYNE PHARMA
CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE;ORAL Prescription No AB1 065017 SANDOZ
GENGRAF CYCLOSPORINE 100MG CAPSULE;ORAL Prescription No AB1 065003 ABBVIE
NEORAL CYCLOSPORINE 100MG CAPSULE;ORAL Prescription Yes AB1 050715 NOVARTIS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English