Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018605
Company: PHARMACIA AND UPJOHN
Company: PHARMACIA AND UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AZULFIDINE | SULFASALAZINE | 250MG/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 12/29/1980 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 07/18/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 12/19/1983 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 02/05/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 07/21/1981 | SUPPL-3 | Labeling |
Label is not available on this site. |