Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008975
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PURIFIED CORTROPHIN GEL | CORTICOTROPIN | 40 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| PURIFIED CORTROPHIN GEL | CORTICOTROPIN | 80 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 06/16/1954 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 02/28/2025 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/008975Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/008975Orig1s016ltr.pdf | |
| 12/13/2024 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/008975s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/008975Orig1s015ltr.pdf | |
| 10/26/2023 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/008975s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/008975Orig1s012ltr.pdf | |
| 10/29/2021 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/008975Orig1s008.pdf |
| 12/08/1977 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/25/1977 | SUPPL-5 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/28/2025 | SUPPL-16 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/008975Orig1s016lbl.pdf | |
| 12/13/2024 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/008975s015lbl.pdf | |
| 10/26/2023 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/008975s012lbl.pdf |