Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062087
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN ESTOLATE | ERYTHROMYCIN ESTOLATE | EQ 250MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 06/14/1979 | 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 |
|---|---|---|---|---|---|
| 04/22/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/19/1990 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |