Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074126
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATENOLOL | ATENOLOL | 50MG | TABLET;ORAL | Discontinued | None | No | No |
ATENOLOL | ATENOLOL | 100MG | TABLET;ORAL | Discontinued | None | No | No |
ATENOLOL | ATENOLOL | 25MG | 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 |
---|---|---|---|---|---|---|---|
03/23/1994 | 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 |
---|---|---|---|---|---|
10/13/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
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08/26/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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08/26/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/26/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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08/26/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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08/26/1998 | SUPPL-5 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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08/16/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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12/13/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
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08/29/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |