Orange Book product · Generic (ANDA)
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE
At a glance
Jun 09, 2022
Approved
Generic (ANDA)
Application
AB3
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 09, 2022
4 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
METFORMIN HYDROCHLORIDE
Strength
1GM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB3
Application
ANDA 212681
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of METFORMIN HYDROCHLORIDE
- 2019RIOMET ERBrand (NDA)
NDA 212595 · SUN PHARM
- 2005GLUMETZABrand (NDA)
NDA 021748 · SANTARUS INC
- 2004FORTAMETBrand (NDA)
NDA 021574 · ANDRX LABS LLC
- 2003RIOMETBrand (NDA)
NDA 021591 · RANBAXY
- 2000GLUCOPHAGE XRBrand (NDA)
NDA 021202 · EMD SERONO INC
- 2025METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 219151 · BIONPHARMA
- 2025METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 215008 · ANNORA PHARMA
- 2024METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 209694 · AUROBINDO PHARMA
- 2024METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 218673 · HARMAN FINOCHEM
- 2024METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211163 · MACLEODS PHARMS LTD
- 2023METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 217631 · LAURUS
- 2023METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 212448 · MICRO LABS
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.
