FDA Orange Book Approved Database

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

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.

U.S.A

RLD : No

TE Code :

HYDROCHLOROTHIAZIDE

Brand Name : ORETIC

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 1982-01-01

Application Number : 11971

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

03

ABBVIE

U.S.A

RLD : Yes

TE Code :

HYDROCODONE BITARTRATE; IBUPROFEN

Brand Name : VICOPROFEN

Dosage Form : TABLET;ORAL

Dosage Strength : 7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1997-09-23

Application Number : 20716

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

04

ABBVIE

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

Corporate PDF

05

ALLERGAN

U.S.A

RLD :

TE Code :

OnabotulinumtoxinA

Brand Name : BOTOX COSMETIC

Dosage Form : VIAL; SINGLE-USE

Dosage Strength : 50 UNITS/VIAL

Approval Date :

Application Number : 103000

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

06

DR REDDYS LABS SA

CPhI Korea

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

India

RLD : No

TE Code : AB

DOFETILIDE

Brand Name : DOFETILIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.25MG

Approval Date : 2016-06-06

Application Number : 207058

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

07

DR REDDYS LABS INC

CPhI Korea

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

India

RLD : No

TE Code : AB

LEVOFLOXACIN

Brand Name : LEVOFLOXACIN

Dosage Form : TABLET;ORAL

Dosage Strength : 250MG

Approval Date : 2011-06-20

Application Number : 76710

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

08

DR REDDYS LABS SA

CPhI Korea

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 : 40MG

Approval Date : 2011-12-01

Application Number : 78458

RX/OTC/DISCN : RX

RLD : No

TE Code : AB1

Product Web Link

09

STRIDES PHARMA

CPhI WW Frankfurt

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 : AB

METOCLOPRAMIDE HYDROCHLORIDE

Brand Name : METOCLOPRAMIDE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 1985-10-17

Application Number : 70581

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

10

GRANULES

CPhI WW Frankfurt

Booth #H9.1A48

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

India