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

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Dosage Strength : 7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

03

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

04

ABBVIE

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

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

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

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

CHLORZOXAZONE

Brand Name : CHLORZOXAZONE

Dosage Form : TABLET;ORAL

Dosage Strength : 375MG

Approval Date : 2020-07-21

Application Number : 211849

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

08

DR REDDYS LABS INC

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

09

DR REDDYS

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

India

RLD : No

TE Code : AB

METHYLPHENIDATE HYDROCHLORIDE

Brand Name : METHYLPHENIDATE HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 54MG

Approval Date : 2020-07-29

Application Number : 213473

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

10

STRIDES PHARMA

CPhI WW Frankfurt

Booth # 9.1F6 & 9.1G41

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

India