Glucophage | FDA Orange Book | Approved Drug Product List

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

India

RLD : No

TE Code : AB

Brand Name : METFORMIN HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2010-04-22

Application Number : 90564

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

02

DR REDDYS LABS INC

Booth #RH.E02

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

India

RLD : No

TE Code : AB

Brand Name : METFORMIN HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2006-08-23

Application Number : 77787

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

03

MANKIND PHARMA LTD

Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

India

SITAGLIPTIN, METFORMIN HYDROCHLORIDE

RLD :

TE Code :

Brand Name : SITAGLIPTIN AND METFORMIN HCL

Dosage Form : TABLET

Dosage Strength : 1000MG ER TABLET

Approval Date :

Application Number : 218971

RX/OTC/DISCN :

RLD :

TE Code :

Product Web Link

04

GRANULES INDIA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

India

RLD : No

TE Code : AB

Brand Name : METFORMIN HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 850MG

Approval Date : 2010-04-22

Application Number : 90564

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

05

GRANULES INDIA

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

India

RLD : No

TE Code : AB

Brand Name : METFORMIN HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 1GM

Approval Date : 2010-04-22

Application Number : 90564

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

06

GRANULES

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

India

RLD : No

TE Code : AB1

Brand Name : METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG

Approval Date : 2018-03-16

Application Number : 209313

RX/OTC/DISCN : RX

RLD : No

TE Code : AB1

07

GRANULES

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

India

RLD : No

TE Code : AB

Brand Name : METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 750MG

Approval Date : 2018-03-16

Application Number : 209313

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

08

GRANULES

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

India

RLD : No

TE Code : AB3

Brand Name : METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG

Approval Date : 2021-01-12

Application Number : 213344

RX/OTC/DISCN : RX

RLD : No

TE Code : AB3

09

GRANULES

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

India

RLD : No

TE Code : AB3

Brand Name : METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM

Approval Date : 2021-01-12

Application Number : 213344

RX/OTC/DISCN : RX

RLD : No

TE Code : AB3

10

DR REDDYS LABS INC

Booth #RH.E02

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

India

RLD : No

TE Code : AB