Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019261
Company: AKORN

Products on NDA 019261

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PAREMYD	HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE	1%;0.25%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019261

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/1992	ORIG-1	Approval	Type 4 - New Combination	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
11/05/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/08/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
12/04/2001	SUPPL-8	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19261s8lbl.pdf
06/25/1997	SUPPL-5	Labeling		Label is not available on this site.
09/18/1997	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
02/22/1994	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
08/03/1995	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
07/07/1993	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019261

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2001	SUPPL-8	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19261s8lbl.pdf