Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017808
Company: MYLAN IRELAND LTD
Company: MYLAN IRELAND LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIACALCIN | CALCITONIN SALMON | 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| MIACALCIN | CALCITONIN SALMON | 200 IU/ML | 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 |
|---|---|---|---|---|---|---|---|
| 07/03/1986 | 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 |
|---|---|---|---|---|---|
| 09/11/2017 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017808s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017808Orig1s037ltr.pdf | |
| 02/02/2015 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017808s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017808Orig1s036ltr.pdf | |
| 03/11/2014 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017808s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017808Orig1s035ltr.pdf | |
| 04/18/2012 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017808s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017808s034ltr.pdf | |
| 02/19/2013 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/2009 | SUPPL-30 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017808s030lbl.pdf | |
| 06/03/2003 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17808slr024ltr.pdf |
| 02/12/2002 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1999 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/24/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1997 | SUPPL-14 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/017808a_s014.pdf |
| 08/01/1997 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/02/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1995 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/05/1992 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/22/1993 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/01/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/10/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/22/1994 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/03/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/29/1991 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 09/11/2017 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017808s037lbl.pdf | |
| 02/02/2015 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017808s036lbl.pdf | |
| 03/11/2014 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017808s035lbl.pdf | |
| 04/18/2012 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017808s034lbl.pdf | |
| 10/30/2009 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017808s030lbl.pdf |
MIACALCIN
INJECTABLE;INJECTION; 200 IU/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CALCITONIN-SALMON | CALCITONIN SALMON | 200 IU/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212416 | CUSTOPHARM INC |
| CALCITONIN-SALMON | CALCITONIN SALMON | 200 IU/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215715 | DR REDDYS |
| CALCITONIN-SALMON | CALCITONIN SALMON | 200 IU/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209358 | ENDO OPERATIONS |
| MIACALCIN | CALCITONIN SALMON | 200 IU/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017808 | MYLAN IRELAND LTD |