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Details for New Drug Application (NDA): 075440

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NDA 075440 describes HALOPERIDOL DECANOATE, which is a drug marketed by West-ward Pharms Int, Mylan Labs Ltd, Sandoz, Hospira, Fresenius Kabi Usa, and Teva Pharms Usa, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the HALOPERIDOL DECANOATE profile page.

The generic ingredient in HALOPERIDOL DECANOATE is haloperidol decanoate. There are twenty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.

Summary for NDA: 075440

Tradename:
HALOPERIDOL DECANOATE
Applicant:
Mylan Labs Ltd
Ingredient:
haloperidol decanoate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 075440

Suppliers and Packaging for NDA: 075440

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL DECANOATE
haloperidol decanoate
INJECTABLE;INJECTION 075440 ANDA Amneal-Agila, LLC 53150-415 53150-415-10 10 VIAL, SINGLE-DOSE in 1 CARTON (53150-415-10) > 1 mL in 1 VIAL, SINGLE-DOSE (53150-415-01)
HALOPERIDOL DECANOATE
haloperidol decanoate
INJECTABLE;INJECTION 075440 ANDA Amneal-Agila, LLC 53150-422 53150-422-05 5 VIAL, MULTI-DOSE in 1 CARTON (53150-422-05) > 5 mL in 1 VIAL, MULTI-DOSE (53150-422-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Feb 28, 2000TE:AORLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Feb 28, 2000TE:AORLD:No


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