Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080927
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE 7.5MG TABLET;ORAL Discontinued None No No
PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE 15MG TABLET;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/09/1974 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/07/2000 SUPPL-39 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/12/1999 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

02/27/1992 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/27/1992 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/20/1991 SUPPL-34 Labeling

Label is not available on this site.

03/18/1991 SUPPL-33 Labeling

Label is not available on this site.

10/04/1991 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/04/1991 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/04/1991 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

11/13/1989 SUPPL-28 Labeling

Label is not available on this site.

09/11/1989 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/25/1986 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

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