Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210123
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE;INJECTION Prescription AP No No
FLUOROURACIL FLUOROURACIL 1GM/20ML (50MG/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
10/27/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

FLUOROURACIL

INJECTABLE;INJECTION; 500MG/10ML (50MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 040743 ACCORD HLTHCARE
FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 040279 FRESENIUS KABI USA
FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 210123 GLAND PHARMA LTD
FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 203608 SAGENT PHARMS INC
FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 040333 TEVA PHARMS USA

INJECTABLE;INJECTION; 1GM/20ML (50MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOROURACIL FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 040743 ACCORD HLTHCARE
FLUOROURACIL FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 040279 FRESENIUS KABI USA
FLUOROURACIL FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 210123 GLAND PHARMA LTD
FLUOROURACIL FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE;INJECTION Prescription No AP 203608 SAGENT PHARMS INC

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