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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212184
Company: GLENMARK PHARMS LTD

Products on ANDA 212184

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212184

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/03/2021	ORIG-1	Approval		STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212184Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/212184Orig1s000TOC.cfm

Therapeutic Equivalents for ANDA 212184

THEOPHYLLINE

TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THEOCHRON	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	087400	NOSTRUM PHARMS LLC
THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090430	ALEMBIC
THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216276	AMNEAL
THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	217422	ANNORA PHARMA
THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216300	BIONPHARMA
THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212184	GLENMARK PHARMS LTD
THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214806	HARMAN FINOCHEM
THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	089763	HERITAGE PHARMA AVET
THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214950	LEADING
THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214113	RHODES PHARMS
THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216961	TEVA PHARMS INC

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

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