Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006920
Company: LEDERLE
Company: LEDERLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIPLE SULFAS | TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE) | 167MG;167MG;167MG | TABLET;ORAL | Discontinued | None | No | No |
| TRIPLE SULFAS | TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE) | 167MG/5ML;167MG/5ML;167MG/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 |
|---|---|---|---|---|---|---|---|
| 08/16/1949 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 04/17/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/12/1978 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/22/1977 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/17/1977 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |