Details for New Drug Application (NDA): 021346
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NDA 021346 describes RISPERDAL CONSTA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the RISPERDAL CONSTA profile page.
The generic ingredient in RISPERDAL CONSTA is risperidone. There are thirty drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the risperidone profile page.
The generic ingredient in RISPERDAL CONSTA is risperidone. There are thirty drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 021346
| Tradename: | RISPERDAL CONSTA |
| Applicant: | Janssen Pharms |
| Ingredient: | risperidone |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 021346
Suppliers and Packaging for NDA: 021346
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346 | NDA | Janssen Pharmaceuticals, Inc. | 50458-306 | 50458-306-11 | 1 KIT in 1 BOX (50458-306-11) * 2 mL in 1 SYRINGE (50458-306-01) * 2 mL in 1 VIAL |
| RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346 | NDA | Janssen Pharmaceuticals, Inc. | 50458-307 | 50458-307-11 | 1 KIT in 1 BOX (50458-307-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE (50458-307-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR | Strength | 25MG/VIAL | ||||
| Approval Date: | Oct 29, 2003 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR | Strength | 37.5MG/VIAL | ||||
| Approval Date: | Oct 29, 2003 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR | Strength | 50MG/VIAL | ||||
| Approval Date: | Oct 29, 2003 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021346
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-002 | Oct 29, 2003 | 6,368,632*PED | ⤷ Get Started Free |
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-001 | Oct 29, 2003 | 6,194,006*PED | ⤷ Get Started Free |
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-002 | Oct 29, 2003 | 6,264,987*PED | ⤷ Get Started Free |
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-002 | Oct 29, 2003 | 6,379,703*PED | ⤷ Get Started Free |
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-002 | Oct 29, 2003 | 6,544,559 | ⤷ Get Started Free |
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-004 | Apr 12, 2007 | 6,368,632*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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