Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019135
Company: B BRAUN
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/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 |
---|---|---|---|---|---|---|---|
03/29/1985 | 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 |
---|---|---|---|---|---|
03/30/1990 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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11/22/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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10/21/1986 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/10/1985 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |