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Generated: November 21, 2018

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Details for New Drug Application (NDA): 021807

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NDA 021807 describes SOLTAMOX, which is a drug marketed by Midatech Pharma Us and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the SOLTAMOX profile page.

The generic ingredient in SOLTAMOX is tamoxifen citrate. There are sixteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.
Summary for 021807
Applicant:Midatech Pharma Us
Ingredient:tamoxifen citrate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021807
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLTAMOX tamoxifen citrate SOLUTION;ORAL 021807 NDA Rosemont Pharmaceuticals Ltd 13632-123 13632-123-01 1 BOTTLE in 1 CARTON (13632-123-01) > 150 mL in 1 BOTTLE
SOLTAMOX tamoxifen citrate SOLUTION;ORAL 021807 NDA Midatech Pharma US Inc. 89141-123 89141-123-01 1 CONTAINER in 1 CARTON (89141-123-01) > 150 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 20MG BASE/10ML
Approval Date:Oct 29, 2005TE:RLD:No
Patent:➤ Try a Free TrialPatent Expiration:Jun 26, 2018Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson

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