Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091141
Company: TEVA PHARMS USA INC
Company: TEVA PHARMS USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FORMOTEROL FUMARATE | FORMOTEROL FUMARATE | 0.02MG/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 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/091141Orig1s000ltr.pdf |
FORMOTEROL FUMARATE
SOLUTION;INHALATION; 0.02MG/2ML
TE Code = AN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FORMOTEROL FUMARATE | FORMOTEROL FUMARATE | 0.02MG/2ML | SOLUTION;INHALATION | Prescription | No | AN | 215078 | ALEMBIC |
FORMOTEROL FUMARATE | FORMOTEROL FUMARATE | 0.02MG/2ML | SOLUTION;INHALATION | Prescription | No | AN | 215053 | LUPIN |
FORMOTEROL FUMARATE | FORMOTEROL FUMARATE | 0.02MG/2ML | SOLUTION;INHALATION | Prescription | No | AN | 215883 | MANKIND PHARMA |
FORMOTEROL FUMARATE | FORMOTEROL FUMARATE | 0.02MG/2ML | SOLUTION;INHALATION | Prescription | No | AN | 218304 | MICRO LABS |
FORMOTEROL FUMARATE | FORMOTEROL FUMARATE | 0.02MG/2ML | SOLUTION;INHALATION | Prescription | No | AN | 216486 | RITEDOSE CORP |
FORMOTEROL FUMARATE | FORMOTEROL FUMARATE | 0.02MG/2ML | SOLUTION;INHALATION | Prescription | No | AN | 091141 | TEVA PHARMS USA INC |
FORMOTEROL FUMARATE | FORMOTEROL FUMARATE | 0.02MG/2ML | SOLUTION;INHALATION | Prescription | No | AN | 215621 | WILSHIRE PHARMS INC |
PERFOROMIST | FORMOTEROL FUMARATE | 0.02MG/2ML | SOLUTION;INHALATION | Prescription | Yes | AN | 022007 | MYLAN SPECLT |