Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208891
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
WIXELA INHUB | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | AB | No | No |
WIXELA INHUB | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | AB | No | No |
WIXELA INHUB | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
01/30/2019 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208891Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208891Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/208891Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/31/2022 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/30/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208891Orig1s000lbl.pdf |
WIXELA INHUB
POWDER;INHALATION; 0.1MG/INH;EQ 0.05MG BASE/INH
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADVAIR DISKUS 100/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | Yes | AB | 021077 | GLAXO GRP LTD |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 203433 | HIKMA |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 213948 | TEVA PHARMS USA |
WIXELA INHUB | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 208891 | MYLAN |
POWDER;INHALATION; 0.25MG/INH;EQ 0.05MG BASE/INH
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADVAIR DISKUS 250/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | Yes | AB | 021077 | GLAXO GRP LTD |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 203433 | HIKMA |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 213948 | TEVA PHARMS USA |
WIXELA INHUB | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 208891 | MYLAN |
POWDER;INHALATION; 0.5MG/INH;EQ 0.05MG BASE/INH
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADVAIR DISKUS 500/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | Yes | AB | 021077 | GLAXO GRP LTD |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 203433 | HIKMA |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 213948 | TEVA PHARMS USA |
WIXELA INHUB | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 208891 | MYLAN |