Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020859
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SONATA | ZALEPLON | 5MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
SONATA | ZALEPLON | 10MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
08/13/1999 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20859lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20859ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20859_Sonata.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/18/2019 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020859s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020859Orig1s016ltr_rev1rev2LNF.pdf | |
02/06/2019 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020859s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020859Orig1s015ltr.pdf | |
11/21/2012 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/19/2013 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020859s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020859Orig1s013ltr.pdf | |
06/17/2009 | SUPPL-12 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/11/2007 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020859s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020859s009, s011ltr.pdf | |
12/11/2007 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020859s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020859s009, s011ltr.pdf | |
05/19/2003 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20859slr004,005ltr.pdf |
05/19/2003 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20859slr004,005ltr.pdf |
05/31/2002 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20859s002ltr.pdf |
05/31/2002 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20859s002ltr.pdf |
02/22/2001 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20859S1LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20859S1LTR.PDF |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/18/2019 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020859s016lbl.pdf | |
02/06/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020859s015lbl.pdf | |
04/19/2013 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020859s013lbl.pdf | |
12/11/2007 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020859s011lbl.pdf | |
12/11/2007 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020859s009lbl.pdf | |
02/22/2001 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20859S1LBL.PDF | |
08/13/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20859lbl.pdf |
SONATA
CAPSULE;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SONATA | ZALEPLON | 5MG | CAPSULE;ORAL | Prescription | Yes | AB | 020859 | PFIZER |
ZALEPLON | ZALEPLON | 5MG | CAPSULE;ORAL | Prescription | No | AB | 078829 | AUROBINDO PHARMA |
ZALEPLON | ZALEPLON | 5MG | CAPSULE;ORAL | Prescription | No | AB | 077505 | CHARTWELL MOLECULAR |
ZALEPLON | ZALEPLON | 5MG | CAPSULE;ORAL | Prescription | No | AB | 077237 | HIKMA |
ZALEPLON | ZALEPLON | 5MG | CAPSULE;ORAL | Prescription | No | AB | 090374 | ORBION PHARMS |
ZALEPLON | ZALEPLON | 5MG | CAPSULE;ORAL | Prescription | No | AB | 078989 | UNICHEM |
CAPSULE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SONATA | ZALEPLON | 10MG | CAPSULE;ORAL | Prescription | Yes | AB | 020859 | PFIZER |
ZALEPLON | ZALEPLON | 10MG | CAPSULE;ORAL | Prescription | No | AB | 078829 | AUROBINDO PHARMA |
ZALEPLON | ZALEPLON | 10MG | CAPSULE;ORAL | Prescription | No | AB | 077505 | CHARTWELL MOLECULAR |
ZALEPLON | ZALEPLON | 10MG | CAPSULE;ORAL | Prescription | No | AB | 077237 | HIKMA |
ZALEPLON | ZALEPLON | 10MG | CAPSULE;ORAL | Prescription | No | AB | 090374 | ORBION PHARMS |
ZALEPLON | ZALEPLON | 10MG | CAPSULE;ORAL | Prescription | No | AB | 078989 | UNICHEM |