ANDA 204989

SCIEGEN PHARMS INC

FDA Drug Application

Application #204989

Documents

• Letter: 2016-02-22

Application Sponsors

ANDA 204989

SCIEGEN PHARMS INC

Marketing Status

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

Application Products

001	CAPSULE;ORAL	100MG	0	GABAPENTIN	GABAPENTIN
002	CAPSULE;ORAL	300MG	0	GABAPENTIN	GABAPENTIN
003	CAPSULE;ORAL	400MG	0	GABAPENTIN	GABAPENTIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-02-18	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-09-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-09-29	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-09-29	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-09-29	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-09-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	9	Null	7
SUPPL	19	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SCIEGEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204989
            [companyName] => SCIEGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/18\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204989Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/29\/2020","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/29\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/29\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/29\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/29\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-29
        )

)