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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065243

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NDA 065243 describes CLINDAMYCIN HYDROCLHORIDE, which is a drug marketed by Lannett and is included in one NDA. It is available from six suppliers. Additional details are available on the CLINDAMYCIN HYDROCLHORIDE profile page.

The generic ingredient in CLINDAMYCIN HYDROCLHORIDE is clindamycin hydrochloride. There are fifty-three drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the clindamycin hydrochloride profile page.

Summary for 065243

Tradename:2
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065243

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 065243

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 065243 ANDA Lannett Company, Inc. 0527-1383 0527-1383-01 100 CAPSULE in 1 BOTTLE (0527-1383-01)
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 065243 ANDA Lannett Company, Inc. 0527-1383 0527-1383-02 16 CAPSULE in 1 BOTTLE (0527-1383-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 300MG BASE
Approval Date:Aug 12, 2005TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Aug 12, 2005TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Aug 12, 2005TE:ABRLD: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.

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