Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090033
Company: LUPIN LTD
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIFABUTIN | RIFABUTIN | 150MG | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 02/24/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090033Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/12/2024 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/12/2024 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/12/2024 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/10/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/10/2016 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
RIFABUTIN
CAPSULE;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MYCOBUTIN | RIFABUTIN | 150MG | CAPSULE;ORAL | Prescription | Yes | AB | 050689 | PFIZER |
| RIFABUTIN | RIFABUTIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 090033 | LUPIN LTD |
| RIFABUTIN | RIFABUTIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 215041 | NOVITIUM PHARMA |