Details for New Drug Application (NDA): 203383
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The generic ingredient in DICLOFENAC SODIUM 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 203383
Tradename: | DICLOFENAC SODIUM |
Applicant: | Altaire Pharms Inc |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Pharmacology for NDA: 203383
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 203383
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203383 | ANDA | Altaire Pharmaceuticals Inc. | 59390-149 | 59390-149-02 | 1 BOTTLE, DROPPER in 1 CARTON (59390-149-02) / 2.5 mL in 1 BOTTLE, DROPPER |
DICLOFENAC SODIUM | diclofenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203383 | ANDA | Altaire Pharmaceuticals Inc. | 59390-149 | 59390-149-05 | 1 BOTTLE, DROPPER in 1 CARTON (59390-149-05) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.1% | ||||
Approval Date: | Nov 16, 2015 | TE: | AT | RLD: | No |
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