Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018509
Company: MALLINCKRODT INC
Company: MALLINCKRODT INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BAROS | SODIUM BICARBONATE; TARTARIC ACID | 460MG/GM;420MG/GM | GRANULE, EFFERVESCENT;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 08/07/1985 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/06/1994 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 05/04/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |