Application 062475
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DOXY 100 | DOXYCYCLINE HYCLATE | INJECTABLE;INJECTION | EQ 100MG BASE/VIAL | No | Yes |
| 002 | DOXY 200 | DOXYCYCLINE HYCLATE | INJECTABLE;INJECTION | EQ 200MG BASE/VIAL | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51662-1402 | DOXY 100(TM) DOXYCYCLINE | DOXY 100(TM) DOXYCYCLINE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1402 | DOXY 100(TM) DOXYCYCLINE | DOXY 100(TM) DOXYCYCLINE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1402 | DOXY 100(TM) DOXYCYCLINE | DOXY 100(TM) DOXYCYCLINE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 52584-028 | Doxy 100 | Doxycycline | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-028 | Doxy 100 | Doxycycline | General Injectables & Vaccines, Inc | ANDA | Current |
| 63323-130 | Doxy 100 | DOXYCYCLINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-130 | Doxy 100 | DOXYCYCLINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-130 | Doxy 100 | DOXYCYCLINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-130 | Doxy 100 | DOXYCYCLINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-130 | Doxy 100 | DOXYCYCLINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-130 | Doxy 100 | DOXYCYCLINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-130 | Doxy 100 | DOXYCYCLINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-130 | Doxy 100 | DOXYCYCLINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-130 | Doxy 100 | DOXYCYCLINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-130 | Doxy 100 | DOXYCYCLINE | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 18308 | SUPPL | 2014-01-31 |