Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061505
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN STEARATE | ERYTHROMYCIN STEARATE | EQ 250MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| ERYTHROMYCIN STEARATE | ERYTHROMYCIN STEARATE | EQ 500MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 01/16/1973 | 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 |
|---|---|---|---|---|---|
| 08/15/2014 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/22/2003 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/25/1998 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1993 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 06/24/1992 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 10/01/1991 | SUPPL-24 | Bioequivalence |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/24/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |