Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071059
Company: ALRA
Company: ALRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBU-TAB | IBUPROFEN | 600MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 08/11/1988 | 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 |
|---|---|---|---|---|---|
| 10/01/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
IBU-TAB
TABLET;ORAL; 600MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IBU-TAB | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 071059 | ALRA |
| IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 071335 | AMNEAL PHARMS NY |
| IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 078558 | AMNEAL PHARMS NY |
| IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 213794 | AUROBINDO PHARMA LTD |
| IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 071268 | CONTRACT PHARMACAL |
| IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 075682 | DR REDDYS LA |
| IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 076112 | DR REDDYS LABS INC |
| IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 091625 | GRANULES INDIA LTD |
| IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 090796 | MARKSANS PHARMA |
| IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 077114 | PERRIGO PHARMS CO |
| IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 202413 | SHANDONG XINHUA |
| IBUPROFEN | IBUPROFEN | 600MG | TABLET;ORAL | Prescription | No | AB | 078329 | STRIDES PHARMA |
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