Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040287
Company: IVAX SUB TEVA PHARMS

Products on ANDA 040287

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISOLONE	PREDNISOLONE	15MG/5ML	SYRUP;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040287

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40287_Prednisolone_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40287ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040287_prednisolone_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/08/2002	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
11/08/2002	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
02/08/2002	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
11/02/2001	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for ANDA 040287

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40287_Prednisolone_Prntlbl.pdf