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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 204355


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NDA 204355 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 204355
Pharmacology for NDA: 204355
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectDecreased Prostaglandin Production
Suppliers and Packaging for NDA: 204355
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 204355 ANDA Micro Labs Limited 42571-133 42571-133-29 60 BLISTER PACK in 1 CARTON (42571-133-29) / 10 TABLET in 1 BLISTER PACK
DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 204355 ANDA Micro Labs Limited 42571-133 42571-133-30 30 TABLET in 1 BOTTLE (42571-133-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength50MG;0.2MG
Approval Date:Jul 15, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength75MG;0.2MG
Approval Date:Jul 15, 2021TE:ABRLD:No

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