Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074805
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUNISOLIDE | FLUNISOLIDE | 0.025MG/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 |
---|---|---|---|---|---|---|---|
02/20/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74805ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/18/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
FLUNISOLIDE
SPRAY, METERED;NASAL; 0.025MG/SPRAY
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUNISOLIDE | FLUNISOLIDE | 0.025MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 074805 | BAUSCH |
FLUNISOLIDE | FLUNISOLIDE | 0.025MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 207802 | RICONPHARMA LLC |
FLUNISOLIDE | FLUNISOLIDE | 0.025MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 077704 | RISING |