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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065390
Company: CHARTWELL MOLECULAR
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 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
03/28/2008 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
07/21/2022 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

01/19/2022 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

09/13/2021 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

09/02/2020 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

04/14/2020 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/14/2020 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

04/14/2020 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

04/14/2020 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/14/2020 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

06/27/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

06/15/2011 SUPPL-4 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 CHARTWELL MOLECULAR
RIFAMPIN RIFAMPIN 150MG CAPSULE;ORAL Prescription No AB 064150 EPIC PHARMA
RIFAMPIN RIFAMPIN 150MG CAPSULE;ORAL Prescription No AB 090034 LUPIN PHARMS

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 CHARTWELL MOLECULAR
RIFAMPIN RIFAMPIN 300MG CAPSULE;ORAL Prescription No AB 064150 EPIC PHARMA
RIFAMPIN RIFAMPIN 300MG CAPSULE;ORAL Prescription No AB 090034 LUPIN PHARMS
RIMACTANE RIFAMPIN 300MG CAPSULE;ORAL Prescription No AB 050429 OXFORD PHARMS
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