Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008248
Company: BAXTER HLTHCARE CORP
Company: BAXTER HLTHCARE CORP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
WYAMINE SULFATE | MEPHENTERMINE SULFATE | EQ 30MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
WYAMINE SULFATE | MEPHENTERMINE SULFATE | EQ 15MG BASE/ML | 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 |
---|---|---|---|---|---|---|---|
12/29/1951 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
05/31/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
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10/23/1985 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/17/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
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06/07/1978 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |