Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040192
Company: WE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISOLONE PREDNISOLONE 15MG/5ML SYRUP;ORAL Discontinued None 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
05/28/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40192ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40192ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/16/2002 SUPPL-8 Labeling

Label is not available on this site.

04/12/2002 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/28/2000 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/28/2000 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/16/1998 SUPPL-1 Labeling

Label is not available on this site.

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