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Details for New Drug Application (NDA): 078347
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NDA 078347 describes HALOPERIDOL, which is a drug marketed by Alpharma, Lannett Co Inc, Morton Grove, Pharm Assoc, SCS, Teva, Teva Pharms, Abraxis Pharm, Akorn, Baxter Hlthcare Corp, Fosun Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, Smith And Nephew, Solopak, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Cycle Pharms Ltd, Duramed Pharms Barr, Innogenix, Lederle, Mylan, Par Pharm, Purepac Pharm, Quantum Pharmics, Royce Labs, Sandoz, Upsher Smith Labs, Vintage, Zydus Pharms Usa, Hospira, Sandoz Inc, Somerset Theraps Llc, Zydus Pharms, Hikma, and Actavis Mid Atlantic, and is included in one hundred and five NDAs. It is available from twenty-six suppliers. Additional details are available on the HALOPERIDOL profile page.
The generic ingredient in HALOPERIDOL is haloperidol decanoate. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
The generic ingredient in HALOPERIDOL is haloperidol decanoate. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
Summary for 078347
| Tradename: | HALOPERIDOL |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | haloperidol lactate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078347
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HALOPERIDOL | haloperidol lactate | INJECTABLE;INJECTION | 078347 | ANDA | General Injectables and Vaccines, Inc. | 52584-426 | 52584-426-00 | 1 VIAL in 1 BAG (52584-426-00) > 1 mL in 1 VIAL |
| HALOPERIDOL | haloperidol lactate | INJECTABLE;INJECTION | 078347 | ANDA | Cardinal Health | 55154-7076 | 55154-7076-5 | 5 VIAL in 1 BAG (55154-7076-5) > 1 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
| Approval Date: | Sep 14, 2009 | TE: | AP | RLD: | No | ||||
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