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 Milan

Booth #5D18

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

India

RLD : No

TE Code : AP

CARFILZOMIB

Brand Name : CARFILZOMIB

Dosage Form : POWDER;INTRAVENOUS

Dosage Strength : 60MG/VIAL

Approval Date : 2019-09-09

Application Number : 209422

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Product Web Link

04

DR REDDYS LABS SA

CPhI Milan

Booth #5D18

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

India

RLD : No

TE Code :

EXEMESTANE

Brand Name : EXEMESTANE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2019-08-08

Application Number : 208764

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

05

AUCTA

U.S.A

Aucta is a global brand that creates better products from proven molecules.

U.S.A

RLD : No

TE Code : AB

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : ZELVYSIA

Dosage Form : POWDER;ORAL

Dosage Strength : 100MG/PACKET

Approval Date : 2025-04-29

Application Number : 218645

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

06

STRIDES PHARMA

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

India

RLD : No

TE Code : AB1

GABAPENTIN

Brand Name : GABAPENTIN

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date : 2024-12-20

Application Number : 211313

RX/OTC/DISCN : RX

RLD : No

TE Code : AB1

Product Web Link

07

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 : 10MG

Approval Date : 2015-04-13

Application Number : 77712

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 : 5MG

Approval Date : 2009-03-02

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

GABAPENTIN

Brand Name : GABAPENTIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2018-10-16

Application Number : 211314

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

10

GRANULES

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

India