FDA Approval for CORTROSYN issued to AMPHASTAR PHARMS INC
$AMPH
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 016750
Company: AMPHASTAR PHARMS INC
Company: AMPHASTAR PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORTROSYN | COSYNTROPIN | 0.25MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/22/1970 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/2023 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2021 | SUPPL-32 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016750Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/016750Orig1s032ltr.pdf | |
| 09/29/2014 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/2002 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16750slr018ltr.pdf |
| 12/07/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1999 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/29/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1997 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/28/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1988 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1987 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/08/1987 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/10/1987 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1986 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/26/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1982 | SUPPL-2 | 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 |
|---|---|---|---|---|---|
| 12/14/2021 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016750Orig1s032lbl.pdf | |
| 12/14/2021 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016750Orig1s032lbl.pdf |
CORTROSYN
INJECTABLE;INJECTION; 0.25MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CORTROSYN | COSYNTROPIN | 0.25MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 016750 | AMPHASTAR PHARMS INC |
| COSYNTROPIN | COSYNTROPIN | 0.25MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090574 | MYLAN INSTITUTIONAL |
| COSYNTROPIN | COSYNTROPIN | 0.25MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202147 | SANDOZ |