NDA 050278

AVET

FDA Drug Application

Application #050278

Documents

• Letter: 2015-04-29
• Label: 2015-05-12

Application Sponsors

NDA 050278

AVET

Marketing Status

• Prescription: 001
• Prescription: 003

Application Products

001	CAPSULE;ORAL	500MG	1	ACHROMYCIN V	TETRACYCLINE HYDROCHLORIDE
003	CAPSULE;ORAL	250MG	1	ACHROMYCIN V	TETRACYCLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1957-10-08	UNKNOWN
LABELING; Labeling	SUPPL	12	AP	1991-11-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1990-03-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1992-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1958-04-25
LABELING; Labeling	SUPPL	21	AP	1958-05-28
LABELING; Labeling	SUPPL	22	AP	1958-09-15
LABELING; Labeling	SUPPL	23	AP	1958-09-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1958-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1959-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1959-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1960-12-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1960-12-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1961-01-16
LABELING; Labeling	SUPPL	31	AP	1961-03-16
LABELING; Labeling	SUPPL	32	AP	1961-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1999-03-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2015-04-21
LABELING; Labeling	SUPPL	37	AP	2015-04-27	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2016-07-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2016-05-19

Submissions Property Types

SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	33	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	6
SUPPL	39	Null	0
SUPPL	40	Null	0

TE Codes

001	Prescription	AB
003	Prescription	AB

CDER Filings

AVET

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50278
            [companyName] => AVET
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACHROMYCIN V","activeIngredients":"TETRACYCLINE HYDROCHLORIDE","strength":"500MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ACHROMYCIN V","activeIngredients":"TETRACYCLINE HYDROCHLORIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/27\/2015","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050278s037lbl.pdf\"}]","notes":"Please see"},{"actionDate":"04\/27\/2015","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050278s037lbl.pdf\"}]","notes":"Please see"}]
            [originalApprovals] => [{"actionDate":"ACHROMYCIN V","submission":"TETRACYCLINE HYDROCHLORIDE","actionType":"500MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ACHROMYCIN V","submission":"TETRACYCLINE HYDROCHLORIDE","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2015-04-27
        )

)