Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076979
Company: PAR PHARM
Company: PAR PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALCITONIN-SALMON | CALCITONIN SALMON | 200 IU/SPRAY | SPRAY, METERED;NASAL | 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 |
|---|---|---|---|---|---|---|---|
| 06/08/2009 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/076979Orig1s000BioeqR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/26/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/12/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/18/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |