Details for New Drug Application (NDA): 091406
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The generic ingredient in DOXYCYCLINE 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 091406
Tradename: | DOXYCYCLINE |
Applicant: | Mylan Labs Ltd |
Ingredient: | doxycycline hyclate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 091406
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXYCYCLINE | doxycycline hyclate | INJECTABLE;INJECTION | 091406 | ANDA | Henry Schein, Inc | 0404-9855 | 0404-9855-99 | 1 PACKAGE in 1 BAG (0404-9855-99) / 10 mL in 1 PACKAGE |
DOXYCYCLINE | doxycycline hyclate | INJECTABLE;INJECTION | 091406 | ANDA | Mylan Institutional LLC | 67457-437 | 67457-437-10 | 10 VIAL in 1 CARTON (67457-437-10) / 10 mL in 1 VIAL (67457-437-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/VIAL | ||||
Approval Date: | Aug 21, 2012 | TE: | AP | RLD: | No |
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