Details for New Drug Application (NDA): 215583
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The generic ingredient in DOXYCYCLINE HYCLATE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 215583
Tradename: | DOXYCYCLINE HYCLATE |
Applicant: | Gland Pharma Ltd |
Ingredient: | doxycycline hyclate |
Patents: | 0 |
Suppliers and Packaging for NDA: 215583
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXYCYCLINE HYCLATE | doxycycline hyclate | INJECTABLE;INJECTION | 215583 | ANDA | Piramal Critical Care Inc | 66794-237 | 66794-237-41 | 10 VIAL in 1 CARTON (66794-237-41) / 10 mL in 1 VIAL |
DOXYCYCLINE HYCLATE | doxycycline hyclate | INJECTABLE;INJECTION | 215583 | ANDA | Gland Pharma Limited | 68083-481 | 68083-481-10 | 10 VIAL in 1 CARTON (68083-481-10) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/VIAL | ||||
Approval Date: | Apr 12, 2023 | TE: | AP | RLD: | No |
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