Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085075
Company: FLEMING PHARMS
Company: FLEMING PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AEROLATE III | THEOPHYLLINE | 65MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| AEROLATE JR | THEOPHYLLINE | 130MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| AEROLATE SR | THEOPHYLLINE | 260MG | CAPSULE, EXTENDED 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 |
|---|---|---|---|---|---|---|---|
| 11/24/1986 | 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 |
|---|---|---|---|---|---|
| 10/18/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/13/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |