Details for New Drug Application (NDA): 077580
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NDA 077580 describes HALOPERIDOL, which is a drug marketed by Alpharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Rubicon, SCS, Teva, Teva Pharms, Abraxis Pharm, Baxter Hlthcare Corp, Epic Pharma Llc, Fosun Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, Smith And Nephew, Solopak, Teva Pharms Usa, Watson Labs, Actavis Group, Aiping Pharm Inc, Aurobindo Pharma Ltd, Chartwell Rx, Duramed Pharms Barr, Innogenix, Lederle, Mankind Pharma, MSN, Mylan, Par Pharm, Purepac Pharm, Quantum Pharmics, Royce Labs, Sciegen Pharms Inc, Strides Pharma, Upsher Smith Labs, Zydus Pharms Usa, Hospira, Meitheal, Sandoz, Somerset Theraps Llc, Zydus Pharms, and Actavis Mid Atlantic, and is included in one hundred and seven NDAs. It is available from thirty-two 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. Fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
Summary for 077580
| Tradename: | HALOPERIDOL |
| Applicant: | Zydus Pharms Usa |
| Ingredient: | haloperidol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 077580
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HALOPERIDOL | haloperidol | TABLET;ORAL | 077580 | ANDA | Major Pharmaceuticals | 0904-6661 | 0904-6661-04 | 30 BLISTER PACK in 1 CARTON (0904-6661-04) / 1 TABLET in 1 BLISTER PACK |
| HALOPERIDOL | haloperidol | TABLET;ORAL | 077580 | ANDA | Major Pharmaceuticals | 0904-6733 | 0904-6733-61 | 100 BLISTER PACK in 1 CARTON (0904-6733-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Jan 17, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Jan 17, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 29, 2007 | TE: | AB | RLD: | No | ||||
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