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. |
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10/13/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |