Details for New Drug Application (NDA): 021428
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NDA 021428 describes PREVACID, which is a drug marketed by Takeda Pharms Usa, Takeda Pharms Na, and Perrigo Pharma Intl, and is included in six NDAs. It is available from two suppliers. Additional details are available on the PREVACID profile page.
The generic ingredient in PREVACID is lansoprazole; naproxen. There are fifty-six drug master file entries for this compound. Additional details are available on the lansoprazole; naproxen profile page.
The generic ingredient in PREVACID is lansoprazole; naproxen. There are fifty-six drug master file entries for this compound. Additional details are available on the lansoprazole; naproxen profile page.
Summary for 021428
| Tradename: | PREVACID |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | lansoprazole |
| Patents: | 0 |
Pharmacology for NDA: 021428
| Mechanism of Action | Proton Pump Inhibitors |
| Physiological Effect | Inhibition Gastric Acid Secretion |
Medical Subject Heading (MeSH) Categories for 021428
Suppliers and Packaging for NDA: 021428
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428 | NDA | Cardinal Health 107, LLC | 55154-0253 | 55154-0253-0 | 10 BLISTER PACK in 1 BAG (55154-0253-0) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
| PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-543 | 64764-543-05 | 5 BLISTER PACK in 1 TRAY (64764-543-05) / 3 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Strength | 15MG | ||||
| Approval Date: | Aug 30, 2002 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Strength | 30MG | ||||
| Approval Date: | Aug 30, 2002 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021428
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-001 | Aug 30, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-002 | Aug 30, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-001 | Aug 30, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-002 | Aug 30, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-002 | Aug 30, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-001 | Aug 30, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-002 | Aug 30, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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