Details for New Drug Application (NDA): 205241
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The generic ingredient in HALOPERIDOL DECANOATE 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 205241
Tradename: | HALOPERIDOL DECANOATE |
Applicant: | Gland Pharma Ltd |
Ingredient: | haloperidol decanoate |
Patents: | 0 |
Suppliers and Packaging for NDA: 205241
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 205241 | ANDA | Sagent Pharmaceuticals | 25021-831 | 25021-831-01 | 10 VIAL in 1 CARTON (25021-831-01) / 1 mL in 1 VIAL |
HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 205241 | ANDA | Sagent Pharmaceuticals | 25021-833 | 25021-833-01 | 10 VIAL in 1 CARTON (25021-833-01) / 1 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/ML | ||||
Approval Date: | May 12, 2017 | TE: | AO | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/ML | ||||
Approval Date: | May 12, 2017 | TE: | AO | RLD: | No |
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