NDA 009388

TEVA WOMENS

FDA Drug Application

Application #009388

Documents

• Letter: 2022-05-16
• Label: 2022-05-17

Application Sponsors

NDA 009388

TEVA WOMENS

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

DIAMOX

ACETAZOLAMIDE SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1954-06-25	STANDARD
LABELING; Labeling	SUPPL	25	AP	1990-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1990-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1993-12-09	STANDARD
LABELING; Labeling	SUPPL	30	AP	1994-07-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1994-07-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2000-09-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1999-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2002-11-26	STANDARD
LABELING; Labeling	SUPPL	38	AP	2022-05-13	STANDARD

Submissions Property Types

SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	35	Null	0
SUPPL	38	Null	6

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 9388
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)