NDA 020249

MERCK SHARP DOHME

FDA Drug Application

Application #020249

Documents

• Letter: 2001-03-14
• Label: 2002-06-06
• Review: 1999-03-18
• Letter: 2002-06-06
• Letter: 2007-11-08
• Label: 2001-03-14
• Label: 2007-11-07
• Review: 2009-01-12

Application Sponsors

NDA 020249

MERCK SHARP DOHME

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

FAMOTIDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1994-02-18	STANDARD
LABELING; Labeling	SUPPL	2	AP	1995-06-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-03-03	STANDARD
LABELING; Labeling	SUPPL	5	AP	1996-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-08-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	1998-08-12	STANDARD
LABELING; Labeling	SUPPL	8	AP	1997-11-12	STANDARD
LABELING; Labeling	SUPPL	9	AP	1999-03-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	2001-04-25	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2002-06-06	STANDARD
LABELING; Labeling	SUPPL	12	AP	2001-03-14	STANDARD
LABELING; Labeling	SUPPL	13	AP	2007-11-05	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	8

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20249
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER","activeIngredients":"FAMOTIDINE","strength":"0.4MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/05\/2007","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019462s034,019510s031,020249s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2002","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19510s28lbl20249s11lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2001","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20249S12LBL.PDF\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER","submission":"FAMOTIDINE","actionType":"0.4MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2007-11-05
        )

)