Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016000
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SULLA | SULFAMETER | 500MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 07/01/1966 | 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 |
|---|---|---|---|---|---|
| 01/16/1981 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1980 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 06/27/1980 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/10/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 02/13/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/1978 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 08/11/1977 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/1977 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/22/1976 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/1976 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/1975 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/13/1975 | SUPPL-1 |
Label is not available on this site. |