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Details for New Drug Application (NDA): 203887

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NDA 203887 describes DAPSONE, which is a drug marketed by Alvogen, Jacobus, North Creek Pharms, and Nostrum Labs Inc, and is included in five NDAs. It is available from eight suppliers. Additional details are available on the DAPSONE profile page.

The generic ingredient in DAPSONE is dapsone. There are seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dapsone profile page.

Summary for NDA: 203887

Nostrum Labs Inc
Therapeutic Class:Antimycobacterials

Pharmacology for NDA: 203887


Suppliers and Packaging for NDA: 203887

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 203887 ANDA Nostrum Laboratories, Inc. 29033-036 29033-036-30 30 TABLET in 1 BOTTLE (29033-036-30)
TABLET;ORAL 203887 ANDA Nostrum Laboratories, Inc. 29033-037 29033-037-30 30 TABLET in 1 BOTTLE (29033-037-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 6, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:May 6, 2016TE:ABRLD:No

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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.