Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085863
Company: PRECISION DOSE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEOPHYLLINE THEOPHYLLINE 80MG/15ML ELIXIR;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
03/16/1979 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
10/23/2000 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1997 SUPPL-59 Labeling

Label is not available on this site.

01/14/1997 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

04/04/1996 SUPPL-57 Labeling

Label is not available on this site.

07/07/1992 SUPPL-56 Labeling

Label is not available on this site.

04/23/1991 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

03/11/1991 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

03/28/1990 SUPPL-52 Labeling

Label is not available on this site.

10/04/1989 SUPPL-51 Labeling

Label is not available on this site.

02/08/1989 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

02/08/1989 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

12/15/1988 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

12/15/1988 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

12/15/1988 SUPPL-45 Labeling

Label is not available on this site.

03/17/1987 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

02/18/1983 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/21/1970 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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