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Serving leading biopharmaceutical companies globally:

Argus Health
Johnson and Johnson
Express Scripts
Fish and Richardson

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 011483

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NDA 011483 describes SYNALGOS-DC, which is a drug marketed by Sun Pharm Industries and Leitner Pharms and is included in two NDAs. It is available from two suppliers. Additional details are available on the SYNALGOS-DC profile page.

The generic ingredient in SYNALGOS-DC is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.

Summary for 011483

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 011483

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYNALGOS-DC aspirin; caffeine; dihydrocodeine bitartrate CAPSULE;ORAL 011483 NDA Caraco Pharma Inc. 49708-419 49708-419-88 100 CAPSULE in 1 BOTTLE (49708-419-88)
SYNALGOS-DC aspirin; caffeine; dihydrocodeine bitartrate CAPSULE;ORAL 011483 NDA AUTHORIZED GENERIC Caraco Pharmaceutical Laboratories, Ltd 57664-419 57664-419-88 100 CAPSULE in 1 BOTTLE (57664-419-88)

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength356.4MG;30MG;16MG
Approval Date:Sep 6, 1983TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Queensland Health
Chinese Patent Office
US Department of Justice

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