Details for New Drug Application (NDA): 018701
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NDA 018701 describes HALDOL, which is a drug marketed by Ortho Mcneil, Janssen Pharms, and Ortho Mcneil Pharm, and is included in five NDAs. It is available from two suppliers. Additional details are available on the HALDOL profile page.
The generic ingredient in HALDOL is haloperidol. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the haloperidol profile page.
The generic ingredient in HALDOL is haloperidol. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the haloperidol profile page.
Summary for 018701
| Tradename: | HALDOL |
| Applicant: | Janssen Pharms |
| Ingredient: | haloperidol decanoate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 018701
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HALDOL | haloperidol decanoate | INJECTABLE;INJECTION | 018701 | NDA AUTHORIZED GENERIC | Patriot Pharmaceuticals LLC | 10147-0921 | 10147-0921-3 | 3 AMPULE in 1 BOX (10147-0921-3) / 1 mL in 1 AMPULE |
| HALDOL | haloperidol decanoate | INJECTABLE;INJECTION | 018701 | NDA AUTHORIZED GENERIC | Patriot Pharmaceuticals LLC | 10147-0922 | 10147-0922-5 | 5 AMPULE in 1 BOX (10147-0922-5) / 1 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/ML | ||||
| Approval Date: | Jan 14, 1986 | TE: | AO | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/ML | ||||
| Approval Date: | Jan 31, 1997 | TE: | AO | RLD: | Yes | ||||
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