Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090406
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 500MG;EQ 15MG BASE | TABLET;ORAL | Discontinued | None | No | No |
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 850MG;EQ 15MG 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 |
---|---|---|---|---|---|---|---|
02/25/2011 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090406Orig1s000Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/22/2019 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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02/22/2019 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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02/22/2019 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/01/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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05/01/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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11/29/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |