FDA NDA · NDA019261

PAREMYD

Sponsor: EPIC PHARMA LLC

APPLICATION

NDA019261

TYPE

NDA

ORIGINAL APPROVAL

1992-01-30

LATEST ACTION

2013-11-05

ROUTE

OPHTHALMIC

DOSAGE FORM

SOLUTION/DROPS

MARKETING STATUS

Discontinued

Products

PAREMYD · ReferenceDiscontinued

HYDROXYAMPHETAMINE HYDROBROMIDE 1%, TROPICAMIDE 0.25% · SOLUTION/DROPS · OPHTHALMIC

2013-11-05Manufacturing (CMC) · Supplement 13 · standardAP

2013-10-08Manufacturing (CMC) · Supplement 12 · standardAP

2001-12-04Manufacturing (CMC) · Supplement 8 · standard — Label ↗AP

1997-09-18Manufacturing (CMC) · Supplement 4 · standardAP

1997-06-25Labeling · Supplement 5 · standardAP

1995-08-03Manufacturing (CMC) · Supplement 2 · standardAP

1994-02-22Manufacturing (CMC) · Supplement 3 · standardAP

1993-07-07Manufacturing (CMC) · Supplement 1 · standardAP

1992-01-30Type 4 - New Combination · Original · standardAP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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