Details for New Drug Application (NDA): 070278
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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 070278
Tradename: | HALOPERIDOL |
Applicant: | Mylan |
Ingredient: | haloperidol |
Patents: | 0 |
Suppliers and Packaging for NDA: 070278
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL | haloperidol | TABLET;ORAL | 070278 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0214 | 0378-0214-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0214-01) |
HALOPERIDOL | haloperidol | TABLET;ORAL | 070278 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0214 | 0378-0214-10 | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0214-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Jun 10, 1986 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jul 16, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Jul 16, 2009 | TE: | AB | RLD: | No |
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