Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040323
Company: CHARTWELL RX
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREDNISOLONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | AA | No | 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 |
---|---|---|---|---|---|---|---|
05/13/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/40323lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40323ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40323.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/22/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
01/30/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/13/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/40323lbl.pdf |
PREDNISOLONE
SYRUP;ORAL; 15MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PREDNISOLONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040323 | CHARTWELL RX |
PREDNISOLONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040775 | LANNETT CO INC |
PREDNISOLONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040571 | PHARM ASSOC |
PRELONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | No | AA | 089081 | TEVA |