Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207137
Company: AMNEAL PHARMS

• REMS

Products on ANDA 207137

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207137

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2016	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207137Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/31/2024	SUPPL-15	REMS - MODIFIED - D-N-A		Label is not available on this site.
11/20/2025	SUPPL-14	Labeling, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/13/2023	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/10/2019	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/21/2018	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/18/2018	SUPPL-2	REMS-Proposal		Label is not available on this site.
05/22/2017	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.