Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060272
Company: ARBOR PHARMS INC
Company: ARBOR PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
E-MYCIN | ERYTHROMYCIN | 250MG | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
E-MYCIN | ERYTHROMYCIN | 333MG | TABLET, DELAYED RELEASE;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 |
---|---|---|---|---|---|---|---|
06/23/1981 | 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 |
---|---|---|---|---|---|
11/03/1993 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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09/01/1994 | SUPPL-35 | Labeling |
Label is not available on this site. |
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05/06/1999 | SUPPL-34 | Labeling |
Label is not available on this site. |
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09/01/1994 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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11/19/1990 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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03/01/1989 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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12/18/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |