Orange Book product · Brand (NDA)
ACTOS
PIOGLITAZONE HYDROCHLORIDE
At a glance
Jul 15, 1999
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 15, 1999
27 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
PIOGLITAZONE HYDROCHLORIDE
Strength
EQ 15MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021073
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2021PIOGLITAZONE HYDROCHLORIDEGeneric (ANDA)
ANDA 210165 · COREPHARMA
- 2018PIOGLITAZONE HYDROCHLORIDEGeneric (ANDA)
ANDA 207806 · PRINSTON INC
- 2017PIOGLITAZONE HYDROCHLORIDEGeneric (ANDA)
ANDA 206738 · PURACAP PHARM LLC
- 2014PIOGLITAZONE HYDROCHLORIDEGeneric (ANDA)
ANDA 204133 · ANNORA PHARMA
- 2014PIOGLITAZONE HYDROCHLORIDEGeneric (ANDA)
ANDA 077210 · TEVA PHARMS USA
- 2013PIOGLITAZONE HYDROCHLORIDEGeneric (ANDA)
ANDA 078383 · CHARTWELL RX
- 2013PIOGLITAZONE HYDROCHLORIDEGeneric (ANDA)
ANDA 200044 · ACCORD HLTHCARE
- 2013PIOGLITAZONE HYDROCHLORIDEGeneric (ANDA)
ANDA 078670 · AIPING PHARM INC
- 2013PIOGLITAZONE HYDROCHLORIDEGeneric (ANDA)
ANDA 200268 · AUROBINDO PHARMA LTD
- 2013PIOGLITAZONE HYDROCHLORIDEGeneric (ANDA)
ANDA 078472 · PHARMOBEDIENT
- 2013PIOGLITAZONE HYDROCHLORIDEGeneric (ANDA)
ANDA 091298 · TORRENT PHARMS LTD
- 2013PIOGLITAZONE HYDROCHLORIDEGeneric (ANDA)
ANDA 202456 · ZYDUS PHARMS USA INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
