Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018440
Company: ABRAXIS PHARM
Company: ABRAXIS PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| M.V.C. 9+3 | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E | 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/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 |
|---|---|---|---|---|---|---|---|
| 11/06/1981 | 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 |
|---|---|---|---|---|---|
| 07/01/1992 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 06/30/1992 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 11/18/1982 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 05/05/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |