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Serving leading biopharmaceutical companies globally:

Merck
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Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 011790

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NDA 011790 describes ROBAXIN, which is a drug marketed by West-ward Pharms Int and Auxilium Pharms Llc and is included in two NDAs. It is available from three suppliers. Additional details are available on the ROBAXIN profile page.

The generic ingredient in ROBAXIN is methocarbamol. There are twenty-seven drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the methocarbamol profile page.
Summary for 011790
Tradename:ROBAXIN
Applicant:West-ward Pharms Int
Ingredient:methocarbamol
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 011790
Medical Subject Heading (MeSH) Categories for 011790
Suppliers and Packaging for NDA: 011790
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROBAXIN methocarbamol SOLUTION;IM-IV 011790 NDA West-Ward Pharmaceuticals Corp. 0641-6103 0641-6103-25 25 VIAL in 1 CARTON (0641-6103-25) > 10 mL in 1 VIAL (0641-6103-01)
ROBAXIN methocarbamol SOLUTION;IM-IV 011790 NDA West-Ward Pharmaceuticals Corp. 0641-6217 0641-6217-25 25 VIAL in 1 CARTON (0641-6217-25) > 10 mL in 1 VIAL (0641-6217-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IM-IVStrength1GM/10ML (100MG/ML)
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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AstraZeneca
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