Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062758
Company: ALRA
Company: ALRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERYZOLE | ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL | EQ 200MG BASE/5ML;EQ 600MG BASE/5ML | GRANULE;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 |
---|---|---|---|---|---|---|---|
06/15/1988 | 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 |
---|---|---|---|---|---|
02/07/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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10/28/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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03/03/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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11/03/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |