Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088508
Company: KING PHARMS

Products on ANDA 088508

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TUSSIGON	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088508

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/1985	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
06/28/2018	SUPPL-21	Labeling-Medication Guide		Label is not available on this site.
06/28/2018	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/28/2018	SUPPL-19	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
01/13/2017	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
12/15/2016	SUPPL-17	Labeling-Container/Carton Labels		Label is not available on this site.
11/22/1994	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/15/1993	SUPPL-7	Labeling		Label is not available on this site.
12/15/1992	SUPPL-6	Labeling		Label is not available on this site.
01/23/1991	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/06/1989	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/06/1989	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/06/1989	SUPPL-2	Labeling		Label is not available on this site.
03/31/1989	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.