Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 212759
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIRFENIDONE PIRFENIDONE 267MG TABLET;ORAL Prescription AB No No
PIRFENIDONE PIRFENIDONE 801MG 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
01/25/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212759Orig1s000ltr.pdf

PIRFENIDONE

TABLET;ORAL; 267MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESBRIET PIRFENIDONE 267MG TABLET;ORAL Prescription Yes AB 208780 GENENTECH INC
PIRFENIDONE PIRFENIDONE 267MG TABLET;ORAL Prescription No AB 212730 ACCORD HLTHCARE
PIRFENIDONE PIRFENIDONE 267MG TABLET;ORAL Prescription No AB 212708 ALEMBIC PHARMS LTD
PIRFENIDONE PIRFENIDONE 267MG TABLET;ORAL Prescription No AB 212570 AMNEAL
PIRFENIDONE PIRFENIDONE 267MG TABLET;ORAL Prescription No AB 212680 MICRO LABS
PIRFENIDONE PIRFENIDONE 267MG TABLET;ORAL Prescription No AB 212772 MSN
PIRFENIDONE PIRFENIDONE 267MG TABLET;ORAL Prescription No AB 212560 SANDOZ INC
PIRFENIDONE PIRFENIDONE 267MG TABLET;ORAL Prescription No AB 212759 TEVA PHARMS USA

TABLET;ORAL; 801MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESBRIET PIRFENIDONE 801MG TABLET;ORAL Prescription Yes AB 208780 GENENTECH INC
PIRFENIDONE PIRFENIDONE 801MG TABLET;ORAL Prescription No AB 212730 ACCORD HLTHCARE
PIRFENIDONE PIRFENIDONE 801MG TABLET;ORAL Prescription No AB 212708 ALEMBIC PHARMS LTD
PIRFENIDONE PIRFENIDONE 801MG TABLET;ORAL Prescription No AB 212570 AMNEAL
PIRFENIDONE PIRFENIDONE 801MG TABLET;ORAL Prescription No AB 212680 MICRO LABS
PIRFENIDONE PIRFENIDONE 801MG TABLET;ORAL Prescription No AB 212772 MSN
PIRFENIDONE PIRFENIDONE 801MG TABLET;ORAL Prescription No AB 212560 SANDOZ INC
PIRFENIDONE PIRFENIDONE 801MG TABLET;ORAL Prescription No AB 212759 TEVA PHARMS 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