Drugs@FDA: FDA Approved Drug Products
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 INC |
| PAROMOMYCIN SULFATE | PAROMOMYCIN SULFATE | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AA | 064171 | SUN PHARM INDS INC |
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