An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 081236
Company: HERITAGE PHARMA AVET

Products on ANDA 081236

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 081236

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/1992	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
05/29/2001	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
10/16/2001	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
07/07/2000	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
10/06/2000	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/11/1996	SUPPL-2	Labeling		Label is not available on this site.
05/11/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 081236

THEOPHYLLINE

TABLET, EXTENDED RELEASE;ORAL; 450MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THEOCHRON	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	087400	NOSTRUM PHARMS LLC
THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090430	ALEMBIC
THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216276	AMNEAL
THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	217422	ANNORA PHARMA
THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216300	BIONPHARMA
THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212184	GLENMARK PHARMS LTD
THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214806	HARMAN FINOCHEM
THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	081236	HERITAGE PHARMA AVET
THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214950	LEADING
THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216961	TEVA PHARMS INC

Top