Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206245
Company: NOVEL LABS INC

• REMS

Products on ANDA 206245

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET;ORAL	Discontinued	None	No	No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET;ORAL	Discontinued	None	No	No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206245

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/01/2016	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
01/08/2026	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-17	REMS - MODIFIED - D-N-A		Label is not available on this site.
03/18/2024	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
03/18/2024	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/20/2018	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-5	REMS - PROPOSAL - D-N-A		Label is not available on this site.
12/18/2017	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
12/18/2017	SUPPL-1	Labeling-Package Insert		Label is not available on this site.