Orange Book product · Brand (NDA)
MONODOX
DOXYCYCLINE
At a glance
Feb 17, 2022
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 17, 2022
4 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
DOXYCYCLINE
Strength
EQ 150MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 050641
Product number
004
Marketing status
RX
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.
- 2006ORACEABrand (NDA)
NDA 050805 · GALDERMA LABS LP
- —VIBRAMYCINBrand (NDA)
NDA 050006 · PFIZER
- 2025DOXYCYCLINEGeneric (ANDA)
ANDA 219978 · AIPING PHARM INC
- 2025DOXYCYCLINEGeneric (ANDA)
ANDA 210381 · MACLEODS PHARMS LTD
- 2025DOXYCYCLINEGeneric (ANDA)
ANDA 217098 · PRINSTON INC
- 2024DOXYCYCLINEGeneric (ANDA)
ANDA 217170 · APOTEX
- 2024DOXYCYCLINEGeneric (ANDA)
ANDA 217674 · ALEMBIC
- 2024DOXYCYCLINEGeneric (ANDA)
ANDA 218034 · DR REDDYS
- 2024DOXYCYCLINEGeneric (ANDA)
ANDA 216631 · LUPIN
- 2021DOXYCYCLINEGeneric (ANDA)
ANDA 208942 · RISING
- 2017DOXYCYCLINEGeneric (ANDA)
ANDA 209396 · DR REDDYS LABS SA
- 2017DOXYCYCLINEGeneric (ANDA)
ANDA 209582 · ZYDUS PHARMS
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.
