Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020004
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER | SODIUM LACTATE | 1.87GM/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 |
|---|---|---|---|---|---|---|---|
| 04/21/1992 | 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 |
|---|---|---|---|---|---|
| 07/01/2002 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 04/15/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/07/2000 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/21/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/21/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |