Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075988
Company: CHARTWELL RX
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE | EQ 5MG BASE/5ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
05/25/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075988_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/05/2024 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
03/05/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
06/09/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |
PREDNISOLONE SODIUM PHOSPHATE
SOLUTION;ORAL; EQ 5MG BASE/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PEDIAPRED | PREDNISOLONE SODIUM PHOSPHATE | EQ 5MG BASE/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 019157 | SETON PHARM |
PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE | EQ 5MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 075988 | CHARTWELL RX |