Orange Book product · Brand (NDA)
PERIOSTAT
DOXYCYCLINE HYCLATE
At a glance
Sep 30, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 30, 1998
28 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
DOXYCYCLINE HYCLATE
Strength
EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 050744
Product number
001
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
- —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
- 2025DOXYCYCLINE HYCLATEGeneric (ANDA)
ANDA 217078 · PRECISION DOSE INC
- 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
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
