Drug Approvals - B Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Bacitracin Injection, 50,000 units/vial, Rx American Pharmaceutical Partners ANDA 65-116 12/3/02 - - - Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Rx Altana, Inc
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
Drug Approval Package Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Blocadren (Timolol Maleate) Tablets Company:--Merck & Co
author: USERNAME
C:\Data\N20330S17AP.doc NDA 20- 330/ S- 017 Page 3 STERILE OPHTHALMIC GEL FORMING SOLUTION TIMOPTIC- XE® 0.25% AND 0.5% (TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION) DESCRIPTION TIMOPTIC- XE (timolol maleate ophthalmic gel forming solution) is a non- selective beta- adrenergic receptor blocking agenttimolol (6.8 mg of ...
author: Michael Puglisi
C:\Data\N19463S26AP.doc NDA 19- 463/ S- 026 Page 3 PRESERVATIVE- FREE STERILE OPHTHALMIC SOLUTION in a Sterile Ophthalmic Unit Dose Dispenser TIMOPTIC® 0.25% AND 0.5% (TIMOLOL MALEATE OPHTHALMIC SOLUTION) in OCUDOSE® (DISPENSER) DESCRIPTION Timolol maleate is a non- selective beta- adrenergic receptor blocking agentTimolol maleate ophthalmic solution is supplied in two...
author: Michael Puglisi
C:\Data\N18086S60AP.doc NDA 18- 086/ S- 060 Page 3 STERILE OPHTHALMIC SOLUTION TIMOPTIC® 0.25% AND 0.5% (TIMOLOL MALEATE OPHTHALMIC SOLUTION) DESCRIPTION TIMOPTIC (timolol maleate ophthalmic solution) is a non- selective beta- adrenergic receptor blocking agenttimolol maleate in...
author: Michael Puglisi
http://www.merck.com/product/usa/pi_circulars/t/timolide/timolide_pi.pdf page 10
duplicates:http://www.merck.com/product/usa/pi_circulars/t/timolide/timolide_pi.pdf
http://www.merck.com/product/usa/pi_circulars/t/timolide/timolide_pi.pdf 7928435 1 TABLETS TIMOLIDE ® (TIMOLOL MALEATE- HYDROCHLOROTHIAZIDE) DESCRIPTION TIMOLIDE * (Timolol Maleate- Hydrochlorothiazide) is for the treatment of hypertension
duplicates:http://www.merck.com/product/usa/pi_circulars/t/timolide/timolide_pi.pdf
FDA Drug Approvals List March 2002 - Drug Approvals for March 2002 Definitions and Notes Original New Drug Applications Original Application #: 020855 Approval Date: 21-MAR-02 Trade Name: MESNA Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: ASTA MEDICA AG Active Ingredient(s): MESNA OTC/RX Status: RX Indication(s): For the use as a prophylactic agent in reducing the incidence of ifosfamide...
TIMPILO Product Monograph Potential Side Effects Side effects reported in clinical and post- marketing experience with TIMOPTIC ® (timolol maleate ophthalmic solution, Merck Frosst Std.), systemic BLOCADREN ® (timolol maleate tablets, Merck Frosst Std.), other timolol maleate formulations and pilocarpine ophthalmic solution may be considered potential side effects of TIMPILO ...
author: Merck Frosst Canada & Co.
subject: 644-a,5,00
TIMPILO Product Monograph page 4
author: Merck Frosst Canada & Co.
subject: 644-a,5,00
http://www.merck.com/product/usa/pi_circulars/t/timoptic/timoptic_xe_pi.pdf 9028714 1 STERILE OPHTHALMIC GEL FORMING SOLUTION TIMOPTIC- XE ® 0.25% AND 0.5% (TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION) DESCRIPTION TIMOPTIC- XE * (timolol maleate ophthalmic gel forming solution) is a non- selective betaadrenergic receptor blocking agenttimolol maleate ophthalmic gel forming solution) 8 The...
http://www.merck.com/product/usa/pi_circulars/t/timoptic/timoptic_optsol_pi.pdf 9391001 1 STERILE OPHTHALMIC SOLUTION TIMOPTIC ® 0.25% AND 0.5% (TIMOLOL MALEATE OPHTHALMIC SOLUTION) DESCRIPTION TIMOPTIC * (timolol maleate ophthalmic solution) is a non- selective beta- adrenergic receptor blocking agentBLOCADREN * (timolol maleate tablets)
http://www.merck.com/product/usa/pi_circulars/t/timoptic/timoptic_ocudose_pi.pdf 9351204 1 PRESERVATIVE- FREE STERILE OPHTHALMIC SOLUTION in a Sterile Ophthalmic Unit Dose Dispenser TIMOPTIC ® 0.25% AND 0.5% (TIMOLOL MALEATE OPHTHALMIC SOLUTION) in OCUDOSE ® (DISPENSER) DESCRIPTION Timolol maleate is a non- selective beta- adrenergic receptor blocking agent
duplicates:http://www.merck.com/product/usa/pi_circulars/t/timoptic/timoptic_ocudose_pi.pdf
http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf 7901233 1 TABLETS BLOCADREN ® (TIMOLOL MALEATE) DESCRIPTION BLOCADREN * (Timolol Maleate) is a non- selective beta- adrenergic receptor blocking agent
duplicates:http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf
http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf page 10
duplicates:http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf
http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf page 9
duplicates:http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf
http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf page 8
duplicates:http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf
http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf page 7
duplicates:http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf
http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf page 6
duplicates:http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf
http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf page 5
duplicates:http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf
http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf page 4
duplicates:http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf
http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf page 3
duplicates:http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf
http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf page 2
duplicates:http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf
http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf page 1
duplicates:http://www.merck.com/product/usa/pi_circulars/b/blocadren/blocadren_pi.pdf
