Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089081
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRELONE PREDNISOLONE 15MG/5ML SYRUP;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
02/04/1986 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/089081_prelone_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/09/2002 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

09/11/2002 SUPPL-22 Labeling

Label is not available on this site.

09/11/2002 SUPPL-21 Labeling

Label is not available on this site.

08/05/1998 SUPPL-20 Labeling

Label is not available on this site.

06/29/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/15/1998 SUPPL-18 Labeling

Label is not available on this site.

07/28/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/10/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/12/1994 SUPPL-15 Labeling

Label is not available on this site.

10/15/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/06/1992 SUPPL-13 Labeling

Label is not available on this site.

09/03/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/03/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/03/1992 SUPPL-10 Labeling

Label is not available on this site.

05/10/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/28/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/28/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/28/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/24/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/24/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/15/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

PRELONE

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 040401 HI TECH PHARMA CO
PREDNISOLONE PREDNISOLONE 15MG/5ML SYRUP;ORAL Prescription No AA 040775 LANNETT CO INC
PREDNISOLONE PREDNISOLONE 15MG/5ML SYRUP;ORAL Prescription No AA 040399 PHARM ASSOC
PREDNISOLONE PREDNISOLONE 15MG/5ML SYRUP;ORAL Prescription No AA 040323 VISTAPHARM
PREDNISOLONE PREDNISOLONE 15MG/5ML SYRUP;ORAL Prescription No AA 040313 WOCKHARDT BIO AG
PRELONE PREDNISOLONE 15MG/5ML SYRUP;ORAL Prescription No AA 089081 TEVA

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