Drugs@FDA: FDA-Approved Drugs
Company: LILLY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EVISTA | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/09/1997 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020815_evista_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/27/2018 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020815s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020815Orig1s034ltr.pdf | |
01/25/2016 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/11/2016 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/13/2007 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022042s000,020815s025ltr.pdf |
07/17/2007 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020815s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020815s018ltr.pdf | |
12/24/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/07/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/13/2002 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
01/17/2002 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/02/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/13/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
06/27/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
06/23/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/09/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/30/1999 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20815S3_Evista_prntlbl_P1.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20815s03ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20815S3_Evista.cfm | |
11/24/1998 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20815s2_Evista.pdf |
10/26/1998 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/27/2018 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020815s034lbl.pdf | |
07/17/2007 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020815s018lbl.pdf | |
09/30/1999 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20815S3_Evista_prntlbl_P1.pdf |
EVISTA
TABLET;ORAL; 60MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EVISTA | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | Yes | AB | 020815 | LILLY |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 208206 | AMNEAL PHARMS |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 204310 | AUROBINDO PHARMA |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 211324 | CADILA PHARMS LTD |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 204491 | GLENMARK PHARMS LTD |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 090842 | INVAGEN PHARMS |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 206384 | SCIEGEN PHARMS INC |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 078193 | TEVA PHARMS USA |
RALOXIFENE HYDROCHLORIDE | RALOXIFENE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 200825 | WATSON LABS INC |