Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203433
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | AB | No | No |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.25MG/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 |
---|---|---|---|---|---|---|---|
12/17/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
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 |
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 |
WIXELA INHUB | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 208891 | MYLAN |
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