Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062563
Company: ELKINS SINN
Company: ELKINS SINN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN | ERYTHROMYCIN LACTOBIONATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ERYTHROMYCIN | ERYTHROMYCIN LACTOBIONATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/28/1985 | 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 |
|---|---|---|---|---|---|
| 03/01/1996 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/18/1995 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1994 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/22/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/01/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 04/22/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 03/18/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/16/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 08/27/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |