Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074209
Company: EUGIA PHARMA
Company: EUGIA PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CROMOLYN SODIUM | CROMOLYN SODIUM | 10MG/ML | SOLUTION;INHALATION | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/1994 | 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 |
|---|---|---|---|---|---|
| 05/26/2004 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/01/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/20/2002 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/20/2002 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/31/2001 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/16/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/18/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/13/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |