Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018684
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRANCHAMIN 4% IN PLASTIC CONTAINER | AMINO ACIDS | 4% (4GM/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 |
|---|---|---|---|---|---|---|---|
| 09/28/1984 | 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 |
|---|---|---|---|---|---|
| 04/24/2003 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18684slr020ltr.pdf |
| 08/14/2001 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/14/2001 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 04/29/1997 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/18/1994 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/30/1994 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/29/1991 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/31/1990 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/11/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 03/26/1991 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/23/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/15/1991 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/26/1989 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/28/1987 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/26/1985 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |