Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076801
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Discontinued | None | No | No |
PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Discontinued | None | No | No |
PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;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 |
---|---|---|---|---|---|---|---|
08/17/2012 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076801Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/29/2018 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
11/29/2018 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
07/21/2015 | SUPPL-2 | Labeling-Package Insert |
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