Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204575
Company: AUROLIFE PHARMA LLC

• REMS

Products on ANDA 204575

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204575

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/02/2016	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
12/22/2025	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/21/2024	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		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, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/04/2021	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/22/2019	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/20/2018	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/18/2018	SUPPL-2	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/15/2018	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204575

HYDROCODONE BITARTRATE AND IBUPROFEN

TABLET;ORAL; 7.5MG;200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET;ORAL	Prescription	No	AB	076604	ACTAVIS LABS FL INC
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET;ORAL	Prescription	No	AB	076642	AMNEAL PHARMS NY
HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET;ORAL	Prescription	No	AB	204575	AUROLIFE PHARMA LLC