FDA Orange Book Approved Database

Attending

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

France

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RLD :

TE Code :

INSULIN GLARGINE RECOMBINANT

Brand Name : LANTUS

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100 UNITS/ML

Approval Date :

Application Number : 21081

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

02

ABBVIE

U.S.A

FNCE

Not Confirmed

U.S.A

RLD : No

TE Code :

HYDROCHLOROTHIAZIDE

Brand Name : ORETIC

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 1982-01-01

Application Number : 11971

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Website

Corporate PDF

03

ABBVIE

U.S.A

FNCE

Not Confirmed

U.S.A

RLD : Yes

TE Code : AB

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Brand Name : COMBIGAN

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.2%;EQ 0.5% BASE

Approval Date : 2007-10-30

Application Number : 21398

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Website

Corporate PDF

04

DR REDDYS LABS SA

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

India

RLD : No

TE Code :

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Brand Name : MICROGESTIN FE 1/20

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.02MG;1MG

Approval Date : 2001-02-05

Application Number : 75647

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

05

DR REDDYS LABS SA

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

India

RLD : No

TE Code : AB

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM;EQ 5MG BASE

Approval Date : 2023-08-09

Application Number : 207678

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

06

DR REDDYS LABS SA

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

India

RLD : No

TE Code : AB1

METHYLPHENIDATE HYDROCHLORIDE

Brand Name : METHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 20MG

Approval Date : 2011-12-01

Application Number : 78458

RX/OTC/DISCN : RX

RLD : No

TE Code : AB1

Product Web Link

07

DR REDDYS LABS SA

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

India

RLD : No

TE Code : AB

MERCAPTOPURINE

Brand Name : MERCAPTOPURINE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 2004-02-11

Application Number : 40461

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

08

DR REDDYS LABS SA

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

India

RLD : No

TE Code :

OXYCODONE HYDROCHLORIDE

Brand Name : OXYCODONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2016-04-29

Application Number : 91313

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

09

BRECKENRIDGE

U.S.A

FNCE

Not Confirmed

U.S.A

RLD : No

TE Code : AB

ASENAPINE MALEATE

Brand Name : ASENAPINE MALEATE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 2.5MG BASE

Approval Date : 2020-12-10

Application Number : 205960

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Website

Corporate PDF

10

STRIDES PHARMA

Booth # 9.1F6 & 9.1G41

Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

India