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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091225

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NDA 091225 describes CLINDAMYCIN HYDROCHLORIDE, which is a drug marketed by Zydus Pharms Usa, Mylan Pharms Inc, Teva, G And W Labs Inc, Aurobindo Pharma, Lannett, Sun Pharm Inds Ltd, Watson Labs, and Epic Pharma Llc, and is included in eleven NDAs. It is available from forty suppliers. Additional details are available on the CLINDAMYCIN HYDROCHLORIDE profile page.

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

Summary for NDA: 091225

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

Pharmacology for NDA: 091225

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 091225

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN HYDROCHLORIDE
clindamycin hydrochloride
CAPSULE;ORAL 091225 ANDA Mylan Pharmaceuticals Inc. 0378-6068 0378-6068-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-6068-01)
CLINDAMYCIN HYDROCHLORIDE
clindamycin hydrochloride
CAPSULE;ORAL 091225 ANDA Mylan Pharmaceuticals Inc. 0378-6068 0378-6068-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-6068-05)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:May 31, 2011TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:May 31, 2011TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 300MG BASE
Approval Date:May 31, 2011TE:RLD:No


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