NDA 016084

CASPER PHARMA LLC

FDA Drug Application

Application #016084

Documents

• Letter: 2002-07-17
• Review: 2007-07-09
• Label: 2018-12-04
• Letter: 2018-12-07
• Label: 2022-08-15
• Letter: 2022-09-19

Application Sponsors

NDA 016084

CASPER PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	100MG	1	ZYLOPRIM	ALLOPURINOL
002	TABLET;ORAL	300MG	1	ZYLOPRIM	ALLOPURINOL
003	TABLET;ORAL	200MG	1	ZYLOPRIM	ALLOPURINOL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1966-08-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1976-01-16	PRIORITY
LABELING; Labeling	SUPPL	21	AP	1976-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1977-04-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1980-01-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1980-02-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1989-05-16	PRIORITY
LABELING; Labeling	SUPPL	30	AP	1985-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1982-12-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1982-06-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1982-06-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1986-01-27	PRIORITY
LABELING; Labeling	SUPPL	35	AP	1982-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1983-06-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1985-02-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1985-06-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1991-07-11	PRIORITY
LABELING; Labeling	SUPPL	41	AP	2002-07-17	STANDARD
LABELING; Labeling	SUPPL	44	AP	2018-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	2022-08-04	STANDARD

Submissions Property Types

SUPPL	19	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	44	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CASPER PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16084
            [companyName] => CASPER PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZYLOPRIM","activeIngredients":"ALLOPURINOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ZYLOPRIM","activeIngredients":"ALLOPURINOL","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/03\/2018","submission":"SUPPL-44","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/016084s044lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZYLOPRIM","submission":"ALLOPURINOL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZYLOPRIM","submission":"ALLOPURINOL","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-03
        )

)