Details for New Drug Application (NDA): 062475
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NDA 062475 describes DOXY 200, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from two suppliers. Additional details are available on the DOXY 200 profile page.
The generic ingredient in DOXY 200 is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
The generic ingredient in DOXY 200 is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 062475
| Tradename: | DOXY 200 |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 062475
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXY 100 | doxycycline hyclate | INJECTABLE;INJECTION | 062475 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1402 | 51662-1402-1 | 10 mL in 1 VIAL (51662-1402-1) |
| DOXY 100 | doxycycline hyclate | INJECTABLE;INJECTION | 062475 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1402 | 51662-1402-3 | 10 POUCH in 1 BOX (51662-1402-3) / 1 VIAL in 1 POUCH (51662-1402-2) / 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: | Dec 9, 1983 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MG BASE/VIAL | ||||
| Approval Date: | Dec 9, 1983 | TE: | AP | RLD: | No | ||||
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