Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019083
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 40MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 80MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 160MG/100ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 11/07/1984 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/15/1990 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/18/1985 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |