Details for New Drug Application (NDA): 018701
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The generic ingredient in HALDOL is haloperidol. There are twenty drug master file entries for this compound. Twenty-three 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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