Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018685
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GAVISCON ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE 80MG;20MG TABLET, CHEWABLE;ORAL Over-the-counter None Yes No
GAVISCON ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE 160MG;40MG TABLET, CHEWABLE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/09/1983 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/13/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/28/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/07/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/17/1998 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/01/1997 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1999 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/25/1995 SUPPL-5 Labeling

Label is not available on this site.

10/01/1991 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/08/1989 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/25/1985 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/01/1984 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

GAVISCON

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, CHEWABLE;ORAL; 80MG;20MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
GAVISCON ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE 80MG;20MG TABLET, CHEWABLE;ORAL Over-the-counter Yes 018685 SANOFI AVENTIS US

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