Orange Book product · Brand (NDA)
DORYX
DOXYCYCLINE HYCLATE
At a glance
Dec 19, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 2014
11 yr 8 mo ago
Today
Patent 8715724 expires
Listed drug product patent expiration.
Feb 03, 2028
in 1 yr 8 mo
Pharmaceutical detail
Active ingredient
DOXYCYCLINE HYCLATE
Strength
EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 050795
Product number
006
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2016ACTICLATE CAPBrand (NDA)
NDA 208253 · CHARTWELL RX
- 2001DORYXBrand (NDA)
NDA 050582 · MAYNE PHARMA
- 1998PERIOSTATBrand (NDA)
NDA 050744 · COLLAGENEX
- —VIBRAMYCINBrand (NDA)
NDA 050007 · PFIZER
- 2026DOXYCYCLINE HYCLATEGeneric (ANDA)
ANDA 203276 · AVET LIFESCIENCES
- 2025DOXYCYCLINE HYCLATEGeneric (ANDA)
ANDA 211137 · MACLEODS PHARMS LTD
- 2025DOXYCYCLINE HYCLATEGeneric (ANDA)
ANDA 218888 · ASPIRO
- 2025DOXYCYCLINE HYCLATEGeneric (ANDA)
ANDA 218753 · DR REDDYS
- 2024DOXYCYCLINE HYCLATEGeneric (ANDA)
ANDA 217487 · AMNEAL
- 2024DOXYCYCLINE HYCLATEGeneric (ANDA)
ANDA 218053 · KINDOS
- 2024DOXYCYCLINE HYCLATEGeneric (ANDA)
ANDA 217854 · HERITAGE
- 2024DOXYCYCLINE HYCLATEGeneric (ANDA)
ANDA 217794 · LUPIN
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8715724 | Feb 03, 2028 | in 1 yr 8 mo | Product |
