Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065173
Company: HERITAGE
Company: HERITAGE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PAROMOMYCIN SULFATE | PAROMOMYCIN SULFATE | EQ 250MG BASE | CAPSULE;ORAL | Prescription | AA,TBD | 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 |
---|---|---|---|---|---|---|---|
12/14/2007 | 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 |
---|---|---|---|---|---|
10/28/2015 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
PAROMOMYCIN SULFATE
CAPSULE;ORAL; EQ 250MG BASE
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PAROMOMYCIN SULFATE | PAROMOMYCIN SULFATE | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AA | 065173 | HERITAGE |