Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020547
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACCOLATE | ZAFIRLUKAST | 20MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| ACCOLATE | ZAFIRLUKAST | 10MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 09/26/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020547Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/29/2016 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/15/2013 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020547s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020547Orig1s033ltr.pdf | |
| 05/15/2013 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/2011 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020547s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020547s031ltr.pdf | |
| 10/13/2010 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020547s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020547s030ltr.pdf | |
| 07/14/2010 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020547s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020547s029ltr.pdf | |
| 08/21/2009 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020547s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020547s027ltr.pdf | |
| 05/29/2008 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020547s025ltr.pdf |
| 06/06/2005 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020547s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020547s022ltr.pdf | |
| 03/26/2004 | SUPPL-19 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20547slr019_accolate_lbl.pdf | |
| 10/31/2003 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20547slr017ltr.pdf |
| 01/08/2001 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/2000 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/2001 | SUPPL-14 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20547s014ltr.pdf |
| 06/12/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/12/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/2000 | SUPPL-11 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20547-S011_Accolate.pdf |
| 09/09/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1999 | SUPPL-8 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20547-s008_accolate.pdf |
| 09/17/1999 | SUPPL-7 | Efficacy-New Indication |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20547s07ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-547-S007_Accolate.cfm |
| 08/17/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/06/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/06/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/28/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/15/2013 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020547s033lbl.pdf | |
| 08/08/2011 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020547s031lbl.pdf | |
| 10/13/2010 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020547s030lbl.pdf | |
| 07/14/2010 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020547s029lbl.pdf | |
| 08/21/2009 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020547s027lbl.pdf | |
| 06/06/2005 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020547s022lbl.pdf | |
| 03/26/2004 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20547slr019_accolate_lbl.pdf |
ACCOLATE
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACCOLATE | ZAFIRLUKAST | 20MG | TABLET;ORAL | Prescription | Yes | AB | 020547 | STRIDES PHARMA |
| ZAFIRLUKAST | ZAFIRLUKAST | 20MG | TABLET;ORAL | Prescription | No | AB | 212475 | ANNORA PHARMA |
| ZAFIRLUKAST | ZAFIRLUKAST | 20MG | TABLET;ORAL | Prescription | No | AB | 213163 | AUROBINDO PHARMA |
| ZAFIRLUKAST | ZAFIRLUKAST | 20MG | TABLET;ORAL | Prescription | No | AB | 090372 | DR REDDYS LABS LTD |
| ZAFIRLUKAST | ZAFIRLUKAST | 20MG | TABLET;ORAL | Prescription | No | AB | 204928 | RISING PHARMS |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACCOLATE | ZAFIRLUKAST | 10MG | TABLET;ORAL | Prescription | Yes | AB | 020547 | STRIDES PHARMA |
| ZAFIRLUKAST | ZAFIRLUKAST | 10MG | TABLET;ORAL | Prescription | No | AB | 212475 | ANNORA PHARMA |
| ZAFIRLUKAST | ZAFIRLUKAST | 10MG | TABLET;ORAL | Prescription | No | AB | 213163 | AUROBINDO PHARMA |
| ZAFIRLUKAST | ZAFIRLUKAST | 10MG | TABLET;ORAL | Prescription | No | AB | 090372 | DR REDDYS LABS LTD |
| ZAFIRLUKAST | ZAFIRLUKAST | 10MG | TABLET;ORAL | Prescription | No | AB | 204928 | RISING PHARMS |