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Details for New Drug Application (NDA): 040314

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NDA 040314 describes TROPICACYL, which is a drug marketed by Akorn and is included in two NDAs. It is available from two suppliers. Additional details are available on the TROPICACYL profile page.

The generic ingredient in TROPICACYL is tropicamide. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the tropicamide profile page.

Summary for NDA: 040314


Pharmacology for NDA: 040314

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 040314

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION/DROPS;OPHTHALMIC 040314 ANDA Akorn, Inc. 17478-101 17478-101-12 1 BOTTLE, DROPPER in 1 CARTON (17478-101-12) > 15 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Sep 29, 2000TE:ATRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.