Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089807
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEOPHYLLINE THEOPHYLLINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
04/30/1990 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
10/16/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

10/06/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1996 SUPPL-7 Labeling

Label is not available on this site.

05/11/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/27/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/01/1992 SUPPL-4 Labeling

Label is not available on this site.

12/29/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/24/1991 SUPPL-2 Labeling

Label is not available on this site.

08/03/1990 SUPPL-1 Labeling

Label is not available on this site.

THEOPHYLLINE

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THEOCHRON THEOPHYLLINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 087400 NOSTRUM PHARMS LLC
THEOPHYLLINE THEOPHYLLINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 089807 HERITAGE PHARMA

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