Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087600
Company: LUITPOLD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOPHYLLINE AMINOPHYLLINE 25MG/ML INJECTABLE;INJECTION Prescription AP 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
08/27/1981 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
08/23/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/2002 SUPPL-21 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/01/1997 SUPPL-20 Labeling

Label is not available on this site.

11/14/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/03/1996 SUPPL-18 Labeling

Label is not available on this site.

02/28/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/14/1994 SUPPL-16 Labeling

Label is not available on this site.

03/04/1994 SUPPL-15 Labeling

Label is not available on this site.

06/19/1990 SUPPL-14 Labeling

Label is not available on this site.

01/09/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/07/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/07/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/07/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/15/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/15/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/15/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/15/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/20/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

AMINOPHYLLINE

INJECTABLE;INJECTION; 25MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMINOPHYLLINE AMINOPHYLLINE 25MG/ML INJECTABLE;INJECTION Prescription No AP 087242 HOSPIRA
AMINOPHYLLINE AMINOPHYLLINE 25MG/ML INJECTABLE;INJECTION Prescription No AP 087600 LUITPOLD

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