Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087400
Company: NOSTRUM PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEOCHRON THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
THEOCHRON THEOPHYLLINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
THEOCHRON THEOPHYLLINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
01/11/1983 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
01/28/1998 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/07/1997 SUPPL-28 Labeling

Label is not available on this site.

07/07/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/07/1997 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/17/1996 SUPPL-25 Labeling

Label is not available on this site.

01/23/1996 SUPPL-24 Labeling

Label is not available on this site.

02/22/1993 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/27/1992 SUPPL-22 Labeling

Label is not available on this site.

09/03/1991 SUPPL-21 Bioequivalence

Label is not available on this site.

05/15/1989 SUPPL-20 Bioequivalence

Label is not available on this site.

04/02/1990 SUPPL-19 Labeling

Label is not available on this site.

10/06/1989 SUPPL-18 Labeling

Label is not available on this site.

03/24/1989 SUPPL-17 Labeling

Label is not available on this site.

06/20/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/11/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/20/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/20/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/25/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/22/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/22/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

THEOCHRON

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

TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THEOCHRON THEOPHYLLINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 087400 NOSTRUM PHARMS LLC
THEOPHYLLINE THEOPHYLLINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 089808 HERITAGE PHARMA

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