Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087563
Company: MONARCH PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUIBRON-T/SR THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE;ORAL Discontinued None 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
06/21/1983 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
05/28/1998 SUPPL-24 Labeling

Label is not available on this site.

05/28/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/23/1997 SUPPL-22 Labeling

Label is not available on this site.

02/07/1997 SUPPL-19 Labeling

Label is not available on this site.

07/22/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/23/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/23/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/23/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/23/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/04/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/20/1991 SUPPL-12 Labeling

Label is not available on this site.

11/17/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/09/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/06/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/06/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/04/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/06/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/06/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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