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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088810
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE INTENSOL PREDNISONE 5MG/ML SOLUTION;ORAL Prescription None 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
02/20/1985 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
12/02/2020 SUPPL-29 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/04/2001 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/11/2001 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/28/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/13/1995 SUPPL-15 Labeling

Label is not available on this site.

02/22/1995 SUPPL-14 Labeling

Label is not available on this site.

10/07/1994 SUPPL-13 Labeling

Label is not available on this site.

03/30/1994 SUPPL-12 Labeling

Label is not available on this site.

10/29/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/10/1991 SUPPL-10 Labeling

Label is not available on this site.

07/10/1991 SUPPL-9 Labeling

Label is not available on this site.

02/05/1990 SUPPL-8 Labeling

Label is not available on this site.

10/13/1989 SUPPL-7 Labeling

Label is not available on this site.

09/11/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/24/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/24/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/29/1988 SUPPL-1 Bioequivalence

Label is not available on this site.

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