Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMICAR | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
06/04/1964 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
02/03/2009 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015230s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/015230s037ltr.pdf | |
08/19/2008 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015230s035, 015197s043ltr.pdf | |
08/24/2004 | SUPPL-31 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15230s031ltr.pdf |
09/02/2003 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf |
09/02/2003 | SUPPL-29 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf |
09/02/2003 | SUPPL-28 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf |
09/14/1999 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/14/1999 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
09/14/1999 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/17/1997 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/16/1997 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
11/04/1986 | SUPPL-22 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
01/17/1986 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
06/06/1983 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
12/10/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
09/22/1982 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
04/03/1990 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
12/22/1980 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
10/17/1978 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/03/2009 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015230s037lbl.pdf | |
08/19/2008 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf |