FDA Orange Book Approved Database

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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

02

LGM PHARMA

U.S.A

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

03

DR REDDYS

CPhI India

Booth #RH.E02

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

India

RLD : No

TE Code :

ACYCLOVIR SODIUM

Brand Name : ACYCLOVIR SODIUM

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 50MG BASE/ML

Approval Date : 2020-06-17

Application Number : 207919

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

04

DR REDDYS LABS INC

CPhI India

Booth #RH.E02

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

05

BRECKENRIDGE

U.S.A

U.S.A

RLD : No

TE Code :

PIROXICAM

Brand Name : PIROXICAM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 20MG

Approval Date : 2018-02-21

Application Number : 208991

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Website

Corporate PDF

06

STRIDES PHARMA

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

07

STRIDES PHARMA

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 : 10MG

Approval Date : 2015-04-13

Application Number : 77712

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

08

STRIDES PHARMA

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

India

RLD : No

TE Code :

CELECOXIB

Brand Name : CELECOXIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Approval Date : 2025-04-29

Application Number : 213127

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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 :

CELECOXIB

Brand Name : CELECOXIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2025-04-29

Application Number : 213127

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

10

GRANULES

CPhI India

Attending

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

India