Orange Book product · Brand (NDA)
ACTOPLUS MET
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
At a glance
Aug 29, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 29, 2005
21 yr 1 mo ago
Today
Patent 9101660 expires
Listed drug product patent expiration.
Jan 22, 2027
in 7 mo
Patent 9320714 expires
Listed drug product patent expiration.
Feb 03, 2029
in 2 yr 8 mo
Pharmaceutical detail
Active ingredient
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Strength
500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021842
Product number
001
Marketing status
DISCN
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.
- 2009ACTOPLUS MET XRBrand (NDA)
NDA 022024 · TAKEDA PHARMS USA
- 2015PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 204802 · MACLEODS PHARMS LTD
- 2014PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 091155 · TEVA PHARMS USA
- 2013PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 091273 · CHARTWELL RX
- 2013PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 200823 · AUROBINDO PHARMA LTD
- 2013PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 202001 · TORRENT PHARMS LTD
- 2011PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 090406 · PHARMOBEDIENT
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9101660 | Jan 22, 2027 | in 7 mo | Product |
| 9320714 | Feb 03, 2029 | in 2 yr 8 mo | Product |
