Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212680
Company: MICRO LABS LTD
Company: MICRO LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PIRFENIDONE | PIRFENIDONE | 267MG | TABLET; ORAL | Prescription | None | No | No |
| PIRFENIDONE | PIRFENIDONE | 801MG | TABLET;ORAL | Prescription | None | No | No |
| PIRFENIDONE | PIRFENIDONE | 534MG | TABLET;ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 06/04/2020 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212680Orig1s000TAltr.pdf |
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