Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 015197
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMICAR | AMINOCAPROIC ACID | 500MG | TABLET;ORAL | Discontinued | None | Yes | No |
| AMICAR | AMINOCAPROIC ACID | 1GM | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 06/03/1964 | 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 |
|---|---|---|---|---|---|
| 08/19/2008 | SUPPL-43 | 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-40 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15230s031ltr.pdf |
| 06/24/2004 | SUPPL-39 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf | |
| 06/24/2004 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf | |
| 06/24/2004 | SUPPL-37 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf | |
| 06/24/2004 | SUPPL-36 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf | |
| 11/27/2000 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/2000 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1999 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1997 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 02/11/1992 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/13/1992 | SUPPL-28 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 06/06/1983 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 12/10/1982 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/22/1982 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/03/1990 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/22/1982 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/1981 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/09/1977 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/19/2008 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf | |
| 06/24/2004 | SUPPL-39 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf |
| 06/24/2004 | SUPPL-38 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf | |
| 06/24/2004 | SUPPL-37 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf | |
| 06/24/2004 | SUPPL-36 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf |