Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211287
Company: LUPIN
Company: LUPIN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TIOTROPIUM BROMIDE | TIOTROPIUM BROMIDE | EQ 0.018MG 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 |
---|---|---|---|---|---|---|---|
06/20/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211287Orig1s000ltr.pdf |
TIOTROPIUM BROMIDE
POWDER;INHALATION; EQ 0.018MG BASE/INH
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SPIRIVA | TIOTROPIUM BROMIDE | EQ 0.018MG BASE/INH | POWDER;INHALATION | Prescription | Yes | AB | 021395 | BOEHRINGER INGELHEIM |
TIOTROPIUM BROMIDE | TIOTROPIUM BROMIDE | EQ 0.018MG BASE/INH | POWDER;INHALATION | Prescription | No | AB | 211287 | LUPIN |