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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200183

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NDA 200183 describes SUMATRIPTAN SUCCINATE, which is a drug marketed by Antares Pharma Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Injectalia, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sagent Agila, Sagent Strides, Sandoz Inc, Sun Pharma Global, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Apotex Inc, Aurobindo Pharma, Hikma Pharms, Mylan, Orchid Hlthcare, Roxane, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirty-two NDAs. It is available from thirty-eight suppliers. Additional details are available on the SUMATRIPTAN SUCCINATE profile page.

The generic ingredient in SUMATRIPTAN SUCCINATE is sumatriptan succinate. There are twenty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.

Summary for 200183

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

Pharmacology for NDA: 200183

Suppliers and Packaging for NDA: 200183

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 200183 ANDA West-Ward Pharmaceuticals Corp 0143-9638 0143-9638-25 25 VIAL in 1 CARTON (0143-9638-25) > .5 mL in 1 VIAL (0143-9638-01)
SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 200183 ANDA West-Ward Pharmaceuticals Corp 0143-9638 0143-9638-05 5 VIAL in 1 CARTON (0143-9638-05) > .5 mL in 1 VIAL (0143-9638-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date:Sep 16, 2013TE:APRLD:No


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