FDA Orange Book Approved Database

Attending

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

France

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

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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

03

ABBVIE

U.S.A

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

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 :

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

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 :

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

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 :

MORPHINE SULFATE

Brand Name : MORPHINE SULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Approval Date : 2022-01-12

Application Number : 207270

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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 : 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

08

BRECKENRIDGE

U.S.A

Not Confirmed

U.S.A

RLD : No

TE Code : AB

ASENAPINE MALEATE

Brand Name : ASENAPINE MALEATE

Dosage Form : TABLET;SUBLINGUAL

Dosage Strength : EQ 10MG 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

09

STRIDES PHARMA

Booth # 9.1F6 & 9.1G41

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

India

RLD : No

TE Code :

HYDROCODONE BITARTRATE; IBUPROFEN

Brand Name : HYDROCODONE BITARTRATE AND IBUPROFEN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;200MG

Approval Date : 2006-11-06

Application Number : 77723

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

10

GRANULES

Booth #H9.1A48

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

India