Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
http://www.fda.gov/cder/orange/appendix_a.txt 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO, SECRETIN...
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 agentTIMOPTIC - XE Sterile Ophthalmic Gel Forming Solution is...
author: Michael Puglisi
C:\Data\N20330S17AP.doc page 1
author: Michael Puglisi
C:\Data\N19463S26AP.doc Timolol maleate ophthalmic solution is supplied in two formulations: Ophthalmic Solution TIMOPTIC (timolol maleate ophthalmic solution), which contains the preservative benzalkonium chloride; and Ophthalmic Solution TIMOPTIC* (timolol maleate ophthalmic solution), the preservative- free formulationTIMOPTIC ...
author: Michael Puglisi
C:\Data\N19463S26AP.doc page 1
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 agentTIMOPTIC Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol ...
author: Michael Puglisi
C:\Data\N18086S60AP.doc page 1
author: Michael Puglisi
FDA Drug Approvals List December 2001 Active Ingredient(s): LISINOPRIL OTC/RX Status: RX Original Abbreviated Application #: 076058 Tentative Approval Date: 21-DEC-01 Trade Name: MIDAZOLAM HCL Dosage Form: SYRUP Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application #: 076134 Tentative Approval Date: 20-DEC-01 Trade Name: LORATADINE Dosage Form...
FDA Drug Approvals List November 2001 REDDY'S LABORATORIES LIMITED Active Ingredient(s): IBUPROFEN OTC/RX Status: RX Original Abbreviated Application # 075347 Approval Date: 16-NOV-01 Trade Name:OMEPRAZOLE Dosage Form: CAPSULE Applicant: ANDRX PHARMACEUTICALS, INC Active Ingredient(s): OMEPRAZOLE OTC/RX Status: RX Original Abbreviated Application # 075682 Approval Date: 14-NOV-01 Trade Name:IBU Dosage Form: TABLET...
FDA Drug Approvals List April 2002 - Drug Approvals for April 2002 Definitions and Notes Original New Drug Applications Original Application #: 021310 Approval Date: 05-APR-02 Trade Name: ALORA Chemical Type: 3 Therapeutic Potential: S Dosage Form: PATCH, CONTROLLED RELEASE Applicant: WATSON LABORATORIES INC Active Ingredient(s): ESTRADIOL OTC/RX Status: RX Indication(s): For the prevention of postmenopausal...
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 agentTIMOPTIC - XE ...
http://www.merck.com/product/usa/pi_circulars/t/timoptic/timoptic_xe_pi.pdf page 1
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 agentTIMOPTIC Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate...
http://www.merck.com/product/usa/pi_circulars/t/timoptic/timoptic_optsol_pi.pdf page 8
http://www.merck.com/product/usa/pi_circulars/t/timoptic/timoptic_optsol_pi.pdf page 1
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/t/timoptic/timoptic_ocudose_pi.pdf page 1
duplicates:http://www.merck.com/product/usa/pi_circulars/t/timoptic/timoptic_ocudose_pi.pdf
http://www.fda.gov/cder/foi/label/2001/18086S54lbl.pdf 9010842 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 agentTIMOPTIC Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate...
author: Joanne Holmes
http://www.fda.gov/cder/foi/label/2001/18086S54lbl.pdf page 8
author: Joanne Holmes
http://www.fda.gov/cder/foi/label/2001/18086S54lbl.pdf page 1
author: Joanne Holmes
http://www.fda.gov/cder/foi/label/2001/19463s022lbl.pdf 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 formulations:...
http://www.fda.gov/cder/foi/label/2001/19463s022lbl.pdf page 1
duplicates:http://www.fda.gov/cder/foi/label/2001/19463s22lbl.pdf
