Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200411
Company: IMPAX LABS INC

• REMS

Products on ANDA 200411

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MORPHINE SULFATE	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	40MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200411

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/2016	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
12/22/2025	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-25	REMS - MODIFIED - D-N-A		Label is not available on this site.
10/09/2025	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/06/2023	SUPPL-21	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
12/06/2023	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/06/2023	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/06/2023	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-10	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/26/2017	SUPPL-6	REMS-Modified		Label is not available on this site.
07/19/2018	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/19/2017	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/30/2016	SUPPL-3	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/20/2016	SUPPL-1	REMS-Modified		Label is not available on this site.