Acetaminophen | FDA Orange Book | Approved Drug Product List

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

India

RLD : No

TE Code : AA

Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Dosage Form : TABLET;ORAL

Dosage Strength : 325MG;50MG;40MG

Approval Date : 2008-12-01

Application Number : 40864

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

02

SANOFI AVENTIS US

France

2024 ACI Convention

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

France

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RLD : No

TE Code :

ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE

Brand Name : TALACEN

Dosage Form : TABLET;ORAL

Dosage Strength : 650MG;EQ 25MG BASE

Approval Date : 1982-09-23

Application Number : 18458

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

03

ABBVIE

U.S.A

2024 ACI Convention

Not Confirmed

U.S.A

RLD : No

TE Code :

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Brand Name : VICODIN HP

Dosage Form : TABLET;ORAL

Dosage Strength : 660MG;10MG

Approval Date : 1996-09-23

Application Number : 40117

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

Corporate PDF

04

LGM PHARMA

U.S.A

BioFlorida Conference

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

U.S.A

RLD : No

TE Code : AA

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

05

DR REDDYS LABS SA

Booth #RH.E02

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

India

RLD : No

TE Code : AA

Brand Name : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 325MG;50MG;40MG

Approval Date : 1986-03-17

Application Number : 89007

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product Web Link

06

MIKART

U.S.A

American Pharma Summit

Exhibiting

As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

U.S.A

RLD : No

TE Code :

Brand Name : ESGIC-PLUS

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG;50MG;40MG

Approval Date : 1996-03-28

Application Number : 40085

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

07

STRIDES PHARMA

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

India

RLD : No

TE Code : AA

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Brand Name : HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Dosage Form : TABLET;ORAL

Dosage Strength : 325MG;10MG

Approval Date : 2000-05-31

Application Number : 40355

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

08

GRANULES

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

India

RLD : No

TE Code :

ACETAMINOPHEN

Brand Name : ACETAMINOPHEN

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 650MG

Approval Date : 2019-04-16

Application Number : 211544

RX/OTC/DISCN : OTC

RLD : No

TE Code :

09

GRANULES

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

India

RLD : No

TE Code : AA

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Brand Name : OXYCODONE AND ACETAMINOPHEN

Dosage Form : TABLET;ORAL

Dosage Strength : 325MG;2.5MG

Approval Date : 2019-10-31

Application Number : 211708

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

10

GRANULES

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

India