Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074830
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.01MG/SPRAY | SPRAY, METERED;NASAL | Prescription | AB | No | 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 |
|---|---|---|---|---|---|---|---|
| 01/25/1999 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74830ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-830_Desmopressin.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2021 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2021 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/14/2015 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/02/2015 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/25/2008 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/21/2004 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/25/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/13/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DESMOPRESSIN ACETATE
SPRAY, METERED;NASAL; 0.01MG/SPRAY
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.01MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 074830 | BAUSCH |
| DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) | DESMOPRESSIN ACETATE | 0.01MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 076703 | APOTEX |
| DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) | DESMOPRESSIN ACETATE | 0.01MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 091345 | ZYDUS PHARMS |