Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 209255
Company: VITRUVIAS THERAP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription AP 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
12/18/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

CYANOCOBALAMIN

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription Yes AP 080737 AM REGENT
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 204829 MYLAN LABS LTD
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 206503 SOMERSET THERAPS LLC
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 209429 SOMERSET THERAPS LLC
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 209255 VITRUVIAS THERAP
CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 080515 WEST-WARD PHARMS INT
VIBISONE CYANOCOBALAMIN 1MG/ML INJECTABLE;INJECTION Prescription No AP 080557 FRESENIUS KABI USA

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