Aluminum Hydroxide / magnesium trisilicate Chewable Tablet

Brand(s)
Gaviscon Chewable
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Glaxosmithkline Consumer Healthcare Lp (2014-08-25)
Oldest Current Product
2011-06-13
License(s)
NDA
RxNORM
CHEWABLE TABLET\ALUMINUM HYDROXIDE:MAGNESIUM TRISILICATE
FDAOB
ORAL\TABLET, CHEWABLE\ALUMINUM HYDROXIDE: MAGNESIUM TRISILICATE
SPL Active
ORAL\TABLET, CHEWABLE\ALUMINUM HYDROXIDE: MAGNESIUM TRISILICATE
SPL Moiety
ORAL\TABLET, CHEWABLE\ALUMINUM HYDROXIDE: MAGNESIUM CATION

product(s) by strength(s)

aluminum hydroxide 80 mg / magnesium trisilicate 14.2 mg chewable tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001350096Gaviscon ChewableNDAGlaxosmithkline Consumer Healthcare Lp2011-06-13ALUMINUM HYDROXIDE, MAGNESIUM TRISILICATEORALTABLET, CHEWABLENDA0186857f367927-c366-465c-a059-e2cfb337d562

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA071793FOAMCOATGUARDIAN DRUG CO INC1987-09-04ANDA071793_001
2ANDA072687FOAMICONTrueNOVARTIS CONSUMER HEALTH INC1989-06-28ANDA072687_001
3ANDA089449ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATETruePENNEX PRODUCTS CO INC1987-11-27ANDA089449_001
4NDA018685GAVISCONSANOFI AVENTIS US LLC1983-12-09NDA018685_001, NDA018685_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA071793_001OTCMAGNESIUM TRISILICATE (20MG), ALUMINUM HYDROXIDE (80MG)ORALTABLET, CHEWABLEFalse1987-09-04FOAMCOAT
2ANDA072687_001discontinuedALUMINUM HYDROXIDE (80MG), MAGNESIUM TRISILICATE (20MG)ORALTABLET, CHEWABLEFalse1989-06-28FOAMICON
3ANDA089449_001discontinuedMAGNESIUM TRISILICATE (20MG), ALUMINUM HYDROXIDE (80MG)ORALTABLET, CHEWABLEFalse1987-11-27ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE
4NDA018685_001OTCMAGNESIUM TRISILICATE (20MG), ALUMINUM HYDROXIDE (80MG)ORALTABLET, CHEWABLEFalse1983-12-09GAVISCON
5NDA018685_002OTCALUMINUM HYDROXIDE (160MG), MAGNESIUM TRISILICATE (40MG)ORALTABLET, CHEWABLETrue1983-12-09GAVISCON

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
17f367927-c366-465c-a059-e2cfb337d562 (view SPL)Drug FactsotcHuman OTCGlaxosmithkline Consumer Healthcare Lp2014-08-256001350096, 001350098, 001350430Aluminum Hydroxide / magnesium carbonate Chewable Tablet

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII