Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208150
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
02/29/2016 | ORIG-1 | Approval | 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 |
---|---|---|---|---|---|
10/20/2017 | SUPPL-5 | Labeling-Container/Carton Labels |
Label is not available on this site. |
FLUTICASONE PROPIONATE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPRAY, METERED;NASAL; 0.05MG/SPRAY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
FLONASE ALLERGY RELIEF | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | Yes | 205434 | GLAXOSMITHKLINE CONS |
FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | No | 208024 | AKORN |
FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | No | 208150 | APOTEX |
FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | No | 207957 | HIKMA |
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