U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075964
Company: SUN PHARM INDS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription AB No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/19/2002 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/N75964lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75964ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/10/2024 SUPPL-43 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.
09/06/2022 SUPPL-42 Labeling-Patient Package Insert

Label is not available on this site.
09/06/2022 SUPPL-41 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/06/2022 SUPPL-36 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/06/2022 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/06/2022 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-31 REMS - PROPOSAL - D-N-A

Label is not available on this site.
09/06/2022 SUPPL-29 Labeling-Package Insert

Label is not available on this site.
09/06/2022 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/15/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.
11/22/2010 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
09/27/2002 SUPPL-5 Labeling

Label is not available on this site.
06/16/2003 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/19/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/N75964lbl.pdf

TRAMADOL HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 202075 ACI
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 076003 AMNEAL PHARMS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075981 APOTEX
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 203494 AUROBINDO PHARMA LTD
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 091498 CSPC OUYI PHARM CO
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 201973 IPCA LABS LTD
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 206706 MERRO PHARM USA
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 208708 RUBICON
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075964 SUN PHARM INDS INC
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075977 TEVA
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 211825 UNICHEM
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 090404 ZYDUS PHARMS USA INC
Back to Top