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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076003
Company: AMNEAL PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription AB 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
06/20/2002 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76003ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/05/2024 SUPPL-56 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/18/2023 SUPPL-55 Labeling-Package Insert

Label is not available on this site.
02/07/2023 SUPPL-50 Labeling-Package Insert

Label is not available on this site.
09/21/2022 SUPPL-49 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/21/2022 SUPPL-48 Labeling-Package Insert

Label is not available on this site.
09/21/2022 SUPPL-43 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/21/2022 SUPPL-40 Labeling-Package Insert

Label is not available on this site.
09/21/2022 SUPPL-39 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/21/2022 SUPPL-38 Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-37 REMS - PROPOSAL - D-N-A

Label is not available on this site.
09/21/2022 SUPPL-35 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/21/2022 SUPPL-33 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.
04/16/2015 SUPPL-30 Labeling-Package Insert

Label is not available on this site.
09/30/2011 SUPPL-22 Labeling-Package Insert

Label is not available on this site.
09/27/2013 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
04/16/2015 SUPPL-13 Labeling

Label is not available on this site.
07/26/2004 SUPPL-4 Labeling

Label is not available on this site.
10/29/2002 SUPPL-2 Labeling

Label is not available on this site.
07/18/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/20/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76003lbl.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
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