Drugs@FDA: FDA-Approved Drugs
Company: EPIC PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RIFAMPIN | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | AB | No | No |
RIFAMPIN | RIFAMPIN | 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 |
---|---|---|---|---|---|---|---|
05/28/1997 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064150aplet.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064150review.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/16/2023 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
01/14/2022 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
09/13/2021 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
08/17/2020 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
08/17/2020 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
08/17/2020 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
08/17/2020 | SUPPL-30 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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08/17/2020 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
08/17/2020 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
07/19/2013 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
06/13/2011 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
09/06/2005 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
06/28/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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08/09/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
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02/02/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
03/03/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/19/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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01/02/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
01/02/1998 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
RIFAMPIN
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 | 065390 | CHARTWELL MOLECULAR |
RIFAMPIN | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 064150 | EPIC PHARMA LLC |
RIFAMPIN | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 090034 | LUPIN PHARMS |
RIMACTANE | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 050429 | OXFORD PHARMS |
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 | 065390 | CHARTWELL MOLECULAR |
RIFAMPIN | RIFAMPIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 064150 | EPIC PHARMA LLC |
RIFAMPIN | RIFAMPIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 090034 | LUPIN PHARMS |