Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065421
Company: MYLAN LABS LTD
Company: MYLAN LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RIFAMPIN | RIFAMPIN | 600MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
05/22/2008 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
02/15/2024 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
02/15/2024 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
02/15/2024 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
02/15/2024 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
07/01/2020 | SUPPL-14 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
07/01/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
07/01/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
10/27/2015 | SUPPL-3 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
RIFAMPIN
INJECTABLE;INJECTION; 600MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RIFADIN | RIFAMPIN | 600MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050627 | SANOFI AVENTIS US |
RIFAMPIN | RIFAMPIN | 600MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065502 | EPIC PHARMA LLC |
RIFAMPIN | RIFAMPIN | 600MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091181 | FRESENIUS KABI USA |
RIFAMPIN | RIFAMPIN | 600MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 064217 | HIKMA |
RIFAMPIN | RIFAMPIN | 600MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205039 | HIKMA PHARMS |
RIFAMPIN | RIFAMPIN | 600MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065421 | MYLAN LABS LTD |