Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019059
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDERIDE LA 120/50 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE 50MG;120MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
INDERIDE LA 160/50 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE 50MG;160MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
INDERIDE LA 80/50 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE 50MG;80MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No 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
07/03/1985 ORIG-1 Approval Type 3 - New Dosage Form 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
05/03/2001 SUPPL-17 Labeling

Label is not available on this site.

11/01/2001 SUPPL-16 Labeling

Label is not available on this site.

05/08/1998 SUPPL-15 Labeling

Label is not available on this site.

05/14/1990 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/12/1989 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/10/1989 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1989 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1988 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/06/1987 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/12/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/20/1987 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/02/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/20/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1986 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/24/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/22/1985 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

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