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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 205143


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NDA 205143 describes DICLOFENAC SODIUM AND MISOPROSTOL, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Exela Holdings, Micro Labs, Sandoz, Yung Shin Pharm, and Zydus Pharms, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the DICLOFENAC SODIUM AND MISOPROSTOL profile page.

The generic ingredient in DICLOFENAC SODIUM AND MISOPROSTOL is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 205143
Pharmacology for NDA: 205143
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectDecreased Prostaglandin Production
Suppliers and Packaging for NDA: 205143
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 205143 ANDA Proficient Rx LP 71205-865 71205-865-00 100 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-865-00)
DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 205143 ANDA Proficient Rx LP 71205-865 71205-865-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-865-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength50MG;0.2MG
Approval Date:Feb 19, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength75MG;0.2MG
Approval Date:Feb 19, 2020TE:ABRLD:No

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