Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064171
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
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 | 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 |
---|---|---|---|---|---|---|---|
06/30/1997 | 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 |
---|---|---|---|---|---|
07/05/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
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 PHARMS |
PAROMOMYCIN SULFATE | PAROMOMYCIN SULFATE | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AA | 064171 | SUN PHARM INDS INC |