BLA 022175

DIGESTIVE CARE INC

FDA Drug Application

Application #022175

Documents

• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Letter: 2020-03-23
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Other: 2020-03-23
• Letter: 2022-09-29
• Label: 2022-10-11
• Medication Guide: 2022-10-11

Application Sponsors

BLA 022175

DIGESTIVE CARE INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE, DELAYED RELEASE;ORAL	30,250USP UNITS;8,000USP UNITS;28,750USP UNITS	0	PERTZYE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
002	CAPSULE, DELAYED RELEASE;ORAL	60,500USP UNITS;16,000USP UNITS;57,500USP UNITS	0	PERTZYE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
003	CAPSULE, DELAYED RELEASE;ORAL	15,125USP UNITS;4,000USP UNITS;14,375USP UNITS	0	PERTZYE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
004	CAPSULE, DELAYED RELEASE;ORAL	90,750USP UNITS;24,000USP UNITS;86,250USP UNITS	0	PERTZYE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDA	ORIG	1	AP	2012-05-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2016-10-06	UNKNOWN
LABELING; Labeling	SUPPL	4	AP	2017-07-12	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-03-20	STANDARD
LABELING; Labeling	SUPPL	8	AP	2022-09-28	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	4	Null	7
SUPPL	6	Null	7
SUPPL	8	Null	7

CDER Filings

DIGESTIVE CARE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22175
            [companyName] => DIGESTIVE CARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PERTZYE","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"30,250USP UNITS;8,000USP UNITS;28,750USP UNITS","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PERTZYE","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"60,500USP UNITS;16,000USP UNITS;57,500USP UNITS","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PERTZYE","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"15,125USP UNITS;4,000USP UNITS;14,375USP UNITS","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PERTZYE","activeIngredients":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","strength":"90,750USP UNITS;24,000USP UNITS;86,250USP UNITS","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PERTZYE","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"30,250USP UNITS;8,000USP UNITS;28,750USP UNITS","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PERTZYE","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"60,500USP UNITS;16,000USP UNITS;57,500USP UNITS","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PERTZYE","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"15,125USP UNITS;4,000USP UNITS;14,375USP UNITS","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PERTZYE","submission":"PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)","actionType":"90,750USP UNITS;24,000USP UNITS;86,250USP UNITS","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)