Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 211495
Company: GENEYORK PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription AB No No
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription AB 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
12/07/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

PREDNISONE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription No AB 211495 GENEYORK PHARMS
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription No AB 040581 VINTAGE PHARMS
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription No AB 087801 WEST-WARD PHARMS INT

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 211495 GENEYORK PHARMS
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 040362 JUBILANT CADISTA
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 080292 MYLAN
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 089247 SUN PHARM INDUSTRIES
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 040256 VINTAGE PHARMS
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 080356 WATSON LABS
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 080352 WEST-WARD PHARMS INT

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