Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090034
Company: LUPIN PHARMS
Company: LUPIN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RIFAMPIN | RIFAMPIN | 150MG | CAPSULE;ORAL | Prescription | AB | No | No |
RIFAMPIN | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/21/2013 | 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 |
---|---|---|---|---|---|
08/17/2020 | SUPPL-13 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
03/31/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
03/31/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
03/31/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
03/31/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
03/31/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
RIFAMPIN
CAPSULE;ORAL; 150MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RIFAMPIN | RIFAMPIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 065028 | AKORN |
RIFAMPIN | RIFAMPIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 065390 | LANNETT CO INC |
RIFAMPIN | RIFAMPIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 090034 | LUPIN PHARMS |
RIFAMPIN | RIFAMPIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 064150 | SANDOZ |
CAPSULE;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RIFAMPIN | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 065028 | AKORN |
RIFAMPIN | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 065390 | LANNETT CO INC |
RIFAMPIN | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 090034 | LUPIN PHARMS |
RIFAMPIN | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 064150 | SANDOZ |
RIMACTANE | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 050429 | OXFORD PHARMS |
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