Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018590
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 250MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
10/29/1982 | 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 |
---|---|---|---|---|---|
09/09/1999 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
10/22/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/16/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/19/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/06/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
11/03/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/25/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |