Mylan-Metformin | 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

CPhI Korea

Attending

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

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

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 : 1GM

Approval Date : 2010-04-22

Application Number : 90564

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

05

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

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 : 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

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 : 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

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 : 1GM

Approval Date : 2021-01-12

Application Number : 213344

RX/OTC/DISCN : RX

RLD : No

TE Code : AB3

09

DR REDDYS LABS INC

CPhI Korea

Attending

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 : 850MG

Approval Date : 2006-08-23

Application Number : 77787

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

10

DR REDDYS LABS INC

CPhI Korea

Attending

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

India

RLD : No

TE Code : AB