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Generated: April 25, 2017

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Details for New Drug Application (NDA): 012787

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NDA 012787 describes SYNALAR, which is a drug marketed by Medimetriks Pharms and is included in four NDAs. It is available from three suppliers. Additional details are available on the SYNALAR profile page.

The generic ingredient in SYNALAR is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for NDA: 012787

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Ophthalmic Agents
Otic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 012787

Suppliers and Packaging for NDA: 012787

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYNALAR
fluocinolone acetonide
CREAM;TOPICAL 012787 NDA Medimetriks Pharmaceuticals, Inc. 43538-900 43538-900-12 1 TUBE in 1 CARTON (43538-900-12) > 120 g in 1 TUBE
SYNALAR
fluocinolone acetonide
CREAM;TOPICAL 012787 NDA Medimetriks Pharmaceuticals, Inc. 43538-900 43538-900-99 6 TUBE in 1 CARTON (43538-900-99) > 3 g in 1 TUBE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.025%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.01%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

Summary for product number 005

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.025%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes


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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.

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