Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207306
Company: CIPLA
Company: CIPLA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | AN | 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 |
---|---|---|---|---|---|---|---|
06/22/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207306Orig1s000ltr.pdf |
ARFORMOTEROL TARTRATE
SOLUTION;INHALATION; EQ 0.015MG BASE/2ML
TE Code = AN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 214901 | AIPING PHARM INC |
ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 214779 | ALEMBIC |
ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 213762 | BE PHARMS |
ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 216303 | CF PHARMTECH |
ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 207306 | CIPLA |
ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 215032 | DR REDDYS |
ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 213068 | LUPIN |
ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 216128 | MANKIND PHARMA |
ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 214736 | RITEDOSE CORP |
ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 215385 | SUN PHARM |
ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 200293 | TEVA PHARMS USA |
ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 216815 | WILSHIRE PHARMS INC |
BROVANA | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | Yes | AN | 021912 | LUPIN |