Orange Book product · Brand (NDA)
GLUCOPHAGE
METFORMIN HYDROCHLORIDE
At a glance
Nov 05, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 05, 1998
28 yr ago
Today
Pharmaceutical detail
Active ingredient
METFORMIN HYDROCHLORIDE
Strength
1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 020357
Product number
005
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.
- 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.
