Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 201973
Company: IPCA LABS LTD

• REMS

Products on ANDA 201973

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201973

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2012	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/29/2025	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/31/2024	SUPPL-11	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/15/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/12/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/17/2023	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/17/2023	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/17/2023	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/17/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/17/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-3	REMS - PROPOSAL - D-N-A		Label is not available on this site.
01/17/2023	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/17/2023	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.