Drugs@FDA: FDA-Approved Drugs
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 | 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 |
---|---|---|---|---|---|---|---|
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. |