Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205257
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 No No
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 No No
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 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
12/22/2015 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/2019 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-7 Labeling-Medication Guide, 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.

08/24/2018 SUPPL-5 Labeling-Medication Guide, 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-Medication Guide, Labeling-Package Insert

Label is not available on this site.

TRAMADOL HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 200503 LUPIN LTD
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 205257 MYLAN
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 078783 PAR PHARM INC
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 201384 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 200503 LUPIN LTD
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 205257 MYLAN
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 078783 PAR PHARM INC
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 201384 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 200503 LUPIN LTD
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 205257 MYLAN
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 078783 PAR PHARM INC
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 201384 SUN PHARM

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