Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073543
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATENOLOL | ATENOLOL | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/19/1991 | 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 |
|---|---|---|---|---|---|
| 07/29/2025 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/29/2025 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/14/2005 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/21/2001 | SUPPL-18 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 06/05/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 05/24/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 05/15/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/04/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 01/14/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/17/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/04/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 09/25/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 04/22/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |