Details for New Drug Application (NDA): 204355
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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
Tradename: | DICLOFENAC SODIUM AND MISOPROSTOL |
Applicant: | Micro Labs |
Ingredient: | diclofenac sodium; misoprostol |
Patents: | 0 |
Pharmacology for NDA: 204355
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased 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: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 50MG;0.2MG | ||||
Approval Date: | Jul 15, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 75MG;0.2MG | ||||
Approval Date: | Jul 15, 2021 | TE: | AB | RLD: | No |
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