Drugs@FDA: FDA-Approved Drugs
Company: TEVA PARENTERAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYTARABINE | CYTARABINE | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
CYTARABINE | CYTARABINE | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
CYTARABINE | CYTARABINE | 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
CYTARABINE | CYTARABINE | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
06/17/1969 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/03/2000 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/15/1998 | SUPPL-59 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/016793s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/016793s059ltr.pdf | |
01/24/1996 | SUPPL-58 | Labeling |
Label is not available on this site. |
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11/01/1995 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
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06/14/1995 | SUPPL-56 | Labeling |
Label is not available on this site. |
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09/27/1994 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
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01/08/1990 | SUPPL-52 | Labeling |
Label is not available on this site. |
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12/21/1987 | SUPPL-51 | Labeling |
Label is not available on this site. |
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02/24/1987 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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04/17/1987 | SUPPL-49 | Labeling |
Label is not available on this site. |
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12/21/1987 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/28/1986 | SUPPL-46 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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10/21/1983 | SUPPL-41 | Labeling |
Label is not available on this site. |
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01/31/1986 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/11/1983 | SUPPL-38 | Labeling |
Label is not available on this site. |
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12/30/1982 | SUPPL-37 | Labeling |
Label is not available on this site. |
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03/31/1981 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/23/1979 | SUPPL-33 | Labeling |
Label is not available on this site. |
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10/29/1979 | SUPPL-32 | Labeling |
Label is not available on this site. |
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03/10/1976 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/23/1975 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/24/1974 | SUPPL-25 | Unspecified |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/15/1998 | SUPPL-59 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/016793s059lbl.pdf |