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Details for New Drug Application (NDA): 011483

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NDA 011483 describes SYNALGOS-DC, which is a drug marketed by Sun Pharm Inds 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-four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.

Suppliers and Packaging for NDA: 011483

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
aspirin; caffeine; dihydrocodeine bitartrate
CAPSULE;ORAL 011483 NDA Caraco Pharma Inc. 49708-419 49708-419-88 100 CAPSULE in 1 BOTTLE (49708-419-88)
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.