Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019085
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROVENT IPRATROPIUM BROMIDE 0.018MG/INH AEROSOL, METERED;INHALATION 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
12/29/1986 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/27/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1999 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1998 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/03/1996 SUPPL-14 Labeling

Label is not available on this site.

01/29/1996 SUPPL-13 Labeling

Label is not available on this site.

01/31/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/13/1994 SUPPL-11 Labeling

Label is not available on this site.

05/19/1994 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/1997 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/25/1994 SUPPL-7 Labeling

Label is not available on this site.

01/04/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1992 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1989 SUPPL-4 Labeling

Label is not available on this site.

04/10/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/21/1988 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1988 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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