NDA 012928

LILLY

FDA Drug Application

Application #012928

Application Sponsors

NDA 012928

LILLY

Marketing Status

• Discontinued: 002
• Discontinued: 004
• Discontinued: 006

Application Products

002	SUSPENSION;ORAL	EQ 50MG BASE/5ML	0	NOVRAD	LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS
004	CAPSULE;ORAL	EQ 100MG BASE	0	NOVRAD	LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS
006	CAPSULE;ORAL	EQ 50MG BASE	0	NOVRAD	LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1962-03-21	STANDARD
LABELING; Labeling	SUPPL	2	AP	1972-05-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1976-08-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1976-08-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1976-08-24	STANDARD
LABELING; Labeling	SUPPL	10	AP	1978-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1980-03-11	STANDARD
LABELING; Labeling	SUPPL	12	AP	1981-06-09

Submissions Property Types

SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12928
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)