NDC Code(s) : 70511-131-05, 70511-131-84
Packager : MAIA Pharmaceuticals, Inc.
Category : Human Prescription Drug Label
DEA Schedule : none
Marketing Status : New Drug Application
INGREDIENTS AND APPEARANCE
Sincalide Sincalide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ||||||||||||||||||||
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LABELER - MAIA Pharmaceuticals, Inc.(079211845) |
REGISTRANT - MAIA Pharmaceuticals, Inc.(079211845) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Gland Pharma Limited | 918601238 | MANUFACTURE(70511-131) |
PRINCIPAL DISPLAY PANEL
NDC 70511-131-05
Sincalide for Injection
5 mcg/vial
For Intravenous Use
Vial contains a sterile, lyophilized powder providing 5 mcg sincalide (see insert for inactive ingredients); pH adjusted to 6.5 to 7.5 with hydrochloric acid and/or sodium hydroxide.
Recommended Dosage: See Prescribing Information Single-Dose Vial. Discard Unused Portion.
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]
Manufactured for MAIA Pharmaceuticals, Inc.