Drugs@FDA: FDA-Approved Drugs
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VEPESID | ETOPOSIDE | 50MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
VEPESID | ETOPOSIDE | 100MG | CAPSULE;ORAL | 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 |
---|---|---|---|---|---|---|---|
12/30/1986 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
11/05/2002 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18768slr045,19557slr028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019557_S028_VEPESIDE.pdf | |
11/21/2000 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/02/2000 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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04/02/1999 | SUPPL-23 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19557S023_VePesid.pdf |
01/19/1999 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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12/15/1998 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/17/1995 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/23/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
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03/02/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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05/17/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/01/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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11/01/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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07/14/1989 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/25/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
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08/24/1987 | SUPPL-5 | Labeling |
Label is not available on this site. |
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08/24/1987 | SUPPL-4 | Labeling |
Label is not available on this site. |
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05/20/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
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03/26/1987 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/05/2002 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf |