Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075626
Company: APOTEX INC

Products on ANDA 075626

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075626

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2001	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
06/28/2023	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
06/28/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/09/2016	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
10/20/2004	SUPPL-5	Labeling		Label is not available on this site.
11/20/2002	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.