FDA Orange Book Approved Database

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U.S.A

RLD : Yes

TE Code :

VENETOCLAX

Brand Name : VENCLEXTA

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2016-04-11

Application Number : 208573

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

02

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

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 : 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

Corporate PDF

05

ABBVIE

U.S.A

RLD : Yes

TE Code :

VENETOCLAX

Brand Name : VENCLEXTA

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 2016-04-11

Application Number : 208573

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

06

LGM PHARMA

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

U.S.A

RLD : No

TE Code : AA

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 300MG;50MG;40MG

Approval Date : 2009-11-16

Application Number : 40885

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product Web Link

07

DR REDDYS LABS INC

CPhI Milan

Booth #5D18

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

India

RLD : No

TE Code : AB

RANITIDINE HYDROCHLORIDE

Brand Name : RANITIDINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2005-07-27

Application Number : 76705

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

08

STRIDES PHARMA INTL

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

India

RLD : No

TE Code : AB

OXYCODONE HYDROCHLORIDE

Brand Name : OXYCODONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2015-04-13

Application Number : 77712

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

09

STRIDES PHARMA

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

India

RLD : No

TE Code : AB

CINACALCET HYDROCHLORIDE

Brand Name : CINACALCET HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Approval Date : 2018-04-30

Application Number : 209226

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

10

STRIDES PHARMA INTL

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

India