Details for New Drug Application (NDA): 075440
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NDA 075440 describes HALOPERIDOL DECANOATE, which is a drug marketed by Caplin, Fresenius Kabi Usa, Gland, Hikma, Hospira, Mankind Pharma, Meitheal, Mylan Labs Ltd, Sandoz, Somerset Theraps Llc, Teva Pharms Usa, and Zydus Pharms, and is included in thirteen NDAs. It is available from fourteen 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. Sixteen suppliers are listed for this compound. 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. Sixteen suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
Summary for 075440
| Tradename: | HALOPERIDOL DECANOATE |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | haloperidol decanoate |
| Patents: | 0 |
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 | Mylan Institutional LLC | 67457-409 | 67457-409-13 | 5 VIAL in 1 CARTON (67457-409-13) / 1 mL in 1 VIAL (67457-409-00) |
| HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 075440 | ANDA | Mylan Institutional LLC | 67457-410 | 67457-410-13 | 10 VIAL in 1 CARTON (67457-410-13) / 1 mL in 1 VIAL (67457-410-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/ML | ||||
| Approval Date: | Feb 28, 2000 | TE: | AO | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/ML | ||||
| Approval Date: | Feb 28, 2000 | TE: | AO | RLD: | No | ||||
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