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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020439
Company: THEA PHARMA

Products on NDA 020439

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETIMOL	TIMOLOL	0.25%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No
BETIMOL	TIMOLOL	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020439

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/1995	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/21/2004	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20439s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20439s011ltr.pdf
02/08/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
07/19/2001	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
11/30/1999	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/05/1999	SUPPL-5	Labeling		Label is not available on this site.
03/08/1999	SUPPL-4	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
09/04/1998	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
11/03/1997	SUPPL-2	Labeling		Label is not available on this site.
01/31/1997	SUPPL-1	Manufacturing (CMC)-Expiration Date		Label is not available on this site.

Labels for NDA 020439

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/21/2004	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20439s011lbl.pdf

Therapeutic Equivalents for NDA 020439

BETIMOL

SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETIMOL	TIMOLOL	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	020439	THEA PHARMA
TIMOLOL	TIMOLOL	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	216654	SOMERSET

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