Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204421
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/20/2015 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204421Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204421Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2018 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-6 REMS - PROPOSAL - D-N-A

Label is not available on this site.

09/11/2018 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

08/29/2017 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/21/2017 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/20/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204421Orig1s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English