Drugs@FDA: FDA Approved Drug Products
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 | Prescription | AB | No | No |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 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-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/21/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
PIOGLITAZONE HYDROCHLORIDE
TABLET;ORAL; EQ 15MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACTOS | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021073 | TAKEDA PHARMS USA |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 200044 | ACCORD HLTHCARE |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 200268 | AUROBINDO PHARMA LTD |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 078472 | BRECKENRIDGE PHARM |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 076798 | CELLTRION |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 204133 | LUPIN LTD |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 202467 | MACLEODS PHARMS LTD |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 076801 | MYLAN PHARMS INC |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 078383 | NEOPHARMA |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 207806 | PRINSTON INC |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 206738 | PURACAP PHARM LLC |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 078670 | SANDOZ |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 077210 | TEVA PHARMS USA |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 091298 | TORRENT PHARMS LTD |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 202456 | ZYDUS PHARMS USA INC |
TABLET;ORAL; EQ 30MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACTOS | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021073 | TAKEDA PHARMS USA |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 200044 | ACCORD HLTHCARE |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 200268 | AUROBINDO PHARMA LTD |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 078472 | BRECKENRIDGE PHARM |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 076798 | CELLTRION |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 204133 | LUPIN LTD |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 202467 | MACLEODS PHARMS LTD |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 076801 | MYLAN PHARMS INC |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 078383 | NEOPHARMA |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 207806 | PRINSTON INC |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 206738 | PURACAP PHARM LLC |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 078670 | SANDOZ |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 077210 | TEVA PHARMS USA |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 091298 | TORRENT PHARMS LTD |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 202456 | ZYDUS PHARMS USA INC |
TABLET;ORAL; EQ 45MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACTOS | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021073 | TAKEDA PHARMS USA |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 200044 | ACCORD HLTHCARE |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 200268 | AUROBINDO PHARMA LTD |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 078472 | BRECKENRIDGE PHARM |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 076798 | CELLTRION |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 204133 | LUPIN LTD |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 202467 | MACLEODS PHARMS LTD |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 076801 | MYLAN PHARMS INC |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 078383 | NEOPHARMA |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 207806 | PRINSTON INC |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 206738 | PURACAP PHARM LLC |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 078670 | SANDOZ |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 077210 | TEVA PHARMS USA |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 091298 | TORRENT PHARMS LTD |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 202456 | ZYDUS PHARMS USA INC |
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