Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078355
Company: BELCHER PHARMS
Company: BELCHER PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESLORATADINE | DESLORATADINE | 5MG | TABLET;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 |
---|---|---|---|---|---|---|---|
04/19/2012 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/01/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
05/12/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
DESLORATADINE
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLARINEX | DESLORATADINE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 021165 | ORGANON |
DESLORATADINE | DESLORATADINE | 5MG | TABLET;ORAL | Prescription | No | AB | 078355 | BELCHER PHARMS |
DESLORATADINE | DESLORATADINE | 5MG | TABLET;ORAL | Prescription | No | AB | 078365 | DR REDDYS LABS LTD |
DESLORATADINE | DESLORATADINE | 5MG | TABLET;ORAL | Prescription | No | AB | 078352 | LUPIN PHARMS |
DESLORATADINE | DESLORATADINE | 5MG | TABLET;ORAL | Prescription | No | AB | 078357 | ORBION PHARMS |