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Generated: November 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090108

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NDA 090108 describes CLINDAMYCIN PHOSPHATE, which is a drug marketed by Alvogen Inc, Watson Labs, Wockhardt, Loch, West-ward Pharms Int, Bristol Myers Squibb, Sagent Pharms, Novast Labs Ltd, G And W Labs Inc, Marsam Pharms Llc, Akorn, Solopak, Igi Labs Inc, Vintage Pharms, Fougera Pharms, Teva Parenteral, Boca Pharma Llc, Teligent Pharma Inc, Fresenius Kabi Usa, Abraxis Pharm, Mylan Labs Ltd, Perrigo New York, Fougera Pharms Inc, Bedford, Taro Pharm Inds, Perrigo Uk Finco, Actavis Labs Ut Inc, Perrigo Israel, Mylan Pharms Inc, Tolmar, Actavis Mid Atlantic, Baxter Hlthcare Corp, Akorn Inc, Sandoz Inc, Abbvie, and Baxter Hlthcare, and is included in fifty-eight NDAs. It is available from twenty-two suppliers. Additional details are available on the CLINDAMYCIN PHOSPHATE profile page.

The generic ingredient in CLINDAMYCIN PHOSPHATE is clindamycin phosphate; tretinoin. There are fifty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.

Summary for 090108

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

Pharmacology for NDA: 090108

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 090108

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PHOSPHATE
clindamycin phosphate
INJECTABLE;INJECTION 090108 ANDA Sagent Pharmaceuticals 25021-115 25021-115-02 25 VIAL in 1 CARTON (25021-115-02) > 2 mL in 1 VIAL
CLINDAMYCIN PHOSPHATE
clindamycin phosphate
INJECTABLE;INJECTION 090108 ANDA Sagent Pharmaceuticals 25021-115 25021-115-04 25 VIAL in 1 CARTON (25021-115-04) > 4 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 150MG BASE/ML
Approval Date:Sep 30, 2011TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

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Harvard Business School

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