Details for New Drug Application (NDA): 020353
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The generic ingredient in NAPRELAN is naproxen sodium. There are forty-two drug master file entries for this compound. One hundred and thirty-three suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.
Summary for 020353
Tradename: | NAPRELAN |
Applicant: | Twi Pharms |
Ingredient: | naproxen sodium |
Patents: | 0 |
Pharmacology for NDA: 020353
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 020353
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353 | NDA AUTHORIZED GENERIC | TWi Pharmaceuticals, Inc. | 24979-252 | 24979-252-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-252-01) |
NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353 | NDA AUTHORIZED GENERIC | TWi Pharmaceuticals, Inc. | 24979-253 | 24979-253-68 | 75 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-253-68) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 375MG BASE | ||||
Approval Date: | Jan 5, 1996 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | Jan 5, 1996 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 750MG BASE | ||||
Approval Date: | Jan 5, 1996 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020353
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Twi Pharms | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-001 | Jan 5, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Twi Pharms | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-003 | Jan 5, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Twi Pharms | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-002 | Jan 5, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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