Orange Book product · Brand (NDA)
VIBRAMYCIN
DOXYCYCLINE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
DOXYCYCLINE
Strength
EQ 25MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 050006
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.
- 2006ORACEABrand (NDA)
NDA 050805 · GALDERMA LABS LP
- 1992MONODOXBrand (NDA)
NDA 050641 · CHARTWELL RX
- 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.
