Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077237
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZALEPLON | ZALEPLON | 5MG | CAPSULE;ORAL | Prescription | AB | No | No |
ZALEPLON | ZALEPLON | 10MG | CAPSULE;ORAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
06/06/2008 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077237TA_ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/21/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
10/21/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
03/11/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
ZALEPLON
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 |