Orange Book product · Generic (ANDA)
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE
At a glance
Sep 10, 2018
Approved
Generic (ANDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 10, 2018
7 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
METFORMIN HYDROCHLORIDE
Strength
500MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB1
Application
ANDA 208880
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of METFORMIN HYDROCHLORIDE
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- 2000GLUCOPHAGE XRBrand (NDA)
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ANDA 219151 · BIONPHARMA
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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.
