Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202467
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
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 |
---|---|---|---|---|---|---|---|
02/06/2013 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202467Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/07/2023 | SUPPL-23 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
12/17/2018 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/17/2018 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
01/26/2016 | SUPPL-4 | Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
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 | 204133 | ANNORA PHARMA |
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 | 076798 | CHARTWELL RX |
PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 210165 | COREPHARMA |
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 | 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 | 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 | 204133 | ANNORA PHARMA |
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 | 076798 | CHARTWELL RX |
PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 210165 | COREPHARMA |
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 | 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 | 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 | 204133 | ANNORA PHARMA |
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 | 076798 | CHARTWELL RX |
PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET;ORAL | Prescription | No | AB | 210165 | COREPHARMA |
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 | 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 | 202456 | ZYDUS PHARMS USA INC |