Viewing data from:

TRAMADOL HYDROCHLORIDE

ANDA

TRAMADOL HYDROCHLORIDE | A208708 | RUBICON RESEARCH LTD

4 strengths0 unique patents0 unique exclusivities

API Supply Chain19 active DMFs20 inactive

16 active API suppliers hold Drug Master Files for this ingredient.

WAVELENGTH ENTERPRISES LTDTRAMADOL HYDROCHLORIDE

DMF 119591996

SUN PHARMACEUTICAL INDUSTRIES LTDTRAMADOL HYDROCHLORIDE USP

DMF 160022002

ZYDUS LIFESCIENCES LTDTRAMADOL HYDROCHLORIDE USP

DMF 170372004

PROTO CHEMICALS AGTRAMADOL HYDROCHLORIDE

DMF 171662004

WANBURY LTDTRAMADOL HYDROCHLORIDE

DMF 179702005

JUBILANT BIOSYS LTDTRAMADOL HYDROCHLORIDE USP

DMF 188032005

ARAGEN LIFE SCIENCES LTDTRAMADOL HYDROCHLORIDE

DMF 206322007

CSPC OUYI PHARMACEUTICAL CO LTDTRAMADOL HYDROCHLORIDE

DMF 218052008

RAKS PHARMA PVT LTDTRAMADOL HYDROCHLORIDE USP

DMF 231212009

APITORIA PHARMA PRIVATE LTDTRAMADOL HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE)

DMF 242852010

PIRAMAL PHARMA LTDTRAMADOL HYDROCHLORIDE

DMF 249542011

RAKS PHARMA PVT LTDTRAMADOL HYDROCHLORIDE USP API (PROCESS-2)

DMF 271592013

VIRUPAKSHA ORGANICS LTDTRAMADOL HYDROCHLORIDE

DMF 305042016

UNICHEM LABORATORIES LTDTRAMADOL HYDROCHLORIDE USP

DMF 334242019

MACLEODS PHARMACEUTICALS LTDTRAMADOL HYDROCHLORIDE USP

DMF 336212019

SUN PHARMACEUTICAL INDUSTRIES LTDTramadol Hydrochloride USP (Process-II)

DMF 347452020

EMNAR PHARMA PRIVATE LTDTRAMADOL HYDROCHLORIDE USP

DMF 354452021

SUPRIYA LIFESCIENCE LTDTRAMADOL HYDROCHLORIDE USP

DMF 395332024

SUPRIYA LIFESCIENCE LTDTRAMADOL HYDROCHLORIDE USP-(PROCESS II)

DMF 412262025

NORAMCO DELAWARE INCInactiveTRAMADOL HYDROCHLORIDE

DMF 98071992

GRUNENTHAL GMBHInactiveTRAMADOL HYDROCHLORIDE

DMF 98111992

IROTEC LABORATORIESInactiveTRAMADOL HYDROCHLORIDE

DMF 115261995

HELSINN CHEMICALS SAInactiveTRAMADOL HYDROCHLORIDE

DMF 116051995

ZENTIVA ASInactiveTRAMADOL HYDROCHLORIDE

DMF 124041997

WYCKOFF CHEMICAL CO INCInactiveTRAMADOL HYDROCHLORIDE

DMF 128301998

EXCELLA GMBHInactiveTRAMADOL HYDROCHLORIDE

DMF 128691998

SHIJIAZHUANG PHARMACEUTICAL GROUP CO LTDInactiveTRAMADOL HYDROCHLORIDE USP (BULK)

DMF 143331999

EVONIK TECHNOCHEMIE GMBHInactiveTRAMADOL HYDROCHLORIDE

DMF 145411999

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveTRAMADOL HYDROCHLORIDE

DMF 147612000

DISHMAN PHARMACEUTICALS AND CHEMICALS LTDInactiveTRAMADOL HYDROCHLORIDE

DMF 156302001

DAI-ICHI KARKARIA LTDInactiveTRAMADOL HYDROCHLORIDE EP

DMF 174082004

SHIJIAZHUANG PHARMACEUTICAL GROUP HUASHENG PHARMA CO LTDInactiveTRAMADOL HYDROCHLORIDE EP

DMF 185782005

AREVIPHARMA GMBHInactiveTRAMADOL HYDROCHLORIDE

DMF 191172006

TONIRA PHARMA LTDInactiveTRAMADOL HYDROCHLORIDE

DMF 202042007

ZHEJIANG HISOAR PHARMACEUTICAL CO LTDInactiveTramadol Hydrochloride

DMF 212492007

IPCA LABORATORIES LTDInactiveTRAMADOL HYDROCHLORIDE USP

DMF 216792008

KAMUD DRUGS PVT LTDInactiveTRAMADOL HYDROCHLORIDE BP

DMF 219152008

CADILA HEALTHCARE LTDInactiveTRAMADOL HYDROCHLORIDE

DMF 226872009

IPCA LABORATORIES LTDInactiveTRAMADOL HYDROCHLORIDE (YT3 PROCESS)

DMF 247662011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 7, 2025	SUPPL -21	View Letter (PDF)
Jul 5, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 28, 2019

No patent or exclusivity listings for this strength.

#002 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 28, 2019

#003 — 25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 27, 2023

#004 — 75MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 4, 2024

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Tramadol Hydrochloride applicant name updated from RUBICON to RUBICON RESEARCH for NDA 208708, supplement 003.

Old: RUBICON

New: RUBICON RESEARCH

MODIFIEDApplicant Full Name7/1/2026

Rubicon Research Private Ltd updated its corporate name to Rubicon Research Ltd for tramadol hydrochloride NDA 208708.

Old: RUBICON RESEARCH PRIVATE LTD

New: RUBICON RESEARCH LTD