Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073585
Company: MCNEIL CONS

Products on ANDA 073585

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUDAFED 12 HOUR	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073585

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/1991	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/073585Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/15/2019	SUPPL-20	Labeling-Proprietary Name Change		Label is not available on this site.
11/14/2018	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
11/06/2001	SUPPL-14	Labeling		Label is not available on this site.
09/11/2000	SUPPL-13	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
07/12/1999	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/12/1999	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/12/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/12/1999	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/12/1999	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/12/1999	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/12/1999	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/12/1999	SUPPL-5	Labeling		Label is not available on this site.
01/31/1997	SUPPL-4	Labeling		Label is not available on this site.