.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201692

« Back to Dashboard
NDA 201692 describes CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, which is a drug marketed by Akorn Inc and Sandoz Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER profile page.

The generic ingredient in CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER is clindamycin phosphate. There are fifty-two drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

Summary for NDA: 201692

Tradename:
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
Applicant:
Sandoz Inc
Ingredient:
clindamycin phosphate
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 201692

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 201692

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
clindamycin phosphate
INJECTABLE;INJECTION 201692 ANDA Sandoz Inc 0781-3288 0781-3288-09 24 BAG in 1 CARTON (0781-3288-09) > 50 mL in 1 BAG (0781-3288-91)
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
clindamycin phosphate
INJECTABLE;INJECTION 201692 ANDA Sandoz Inc 0781-3289 0781-3289-09 24 BAG in 1 CARTON (0781-3289-09) > 50 mL in 1 BAG (0781-3289-91)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 6MG BASE/ML
Approval Date:May 31, 2012TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 12MG BASE/ML
Approval Date:May 31, 2012TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 18MG BASE/ML
Approval Date:May 31, 2012TE:APRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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.

`abc