Details for New Drug Application (NDA): 217504
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NDA 217504 describes MIDAZOLAM HYDROCHLORIDE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Endo Operations, Epic Pharma Llc, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, Micro Labs, Rising, Padagis Us, Pai Holdings, Pharm Assoc, Sun Pharm Inds Ltd, Rafa Labs Ltd, and Steriscience Speclts, and is included in thirty-six NDAs. It is available from twenty suppliers. Additional details are available on the MIDAZOLAM HYDROCHLORIDE profile page.
The generic ingredient in MIDAZOLAM HYDROCHLORIDE is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.
The generic ingredient in MIDAZOLAM HYDROCHLORIDE is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.
Summary for 217504
| Tradename: | MIDAZOLAM HYDROCHLORIDE |
| Applicant: | Micro Labs |
| Ingredient: | midazolam hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217504
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 217504 | ANDA | Micro Labs Limited | 42571-414 | 42571-414-87 | 25 VIAL in 1 CARTON (42571-414-87) / 2 mL in 1 VIAL (42571-414-75) |
| MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | INJECTABLE;INJECTION | 217504 | ANDA | Micro Labs Limited | 42571-415 | 42571-415-72 | 10 VIAL in 1 CARTON (42571-415-72) / 1 mL in 1 VIAL (42571-415-54) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
| Approval Date: | Aug 21, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
| Approval Date: | Aug 21, 2023 | TE: | AP | RLD: | No | ||||
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