Orange Book product · Brand (NDA)
ACTISITE
TETRACYCLINE HYDROCHLORIDE
At a glance
Mar 25, 1994
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 25, 1994
32 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
TETRACYCLINE HYDROCHLORIDE
Strength
12.7MG/FIBER
Dosage form
FIBER, EXTENDED RELEASE
Route
PERIODONTAL
TE code
Not listed
Application
NDA 050653
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- —ACHROMYCIN VBrand (NDA)
NDA 050278 · AVET
- —TOPICYCLINEBrand (NDA)
NDA 050493 · SHIRE
- —ACHROMYCINBrand (NDA)
NDA 050273 · LEDERLE
- —ACHROMYCINBrand (NDA)
NDA 050266 · STORZ
- —ACHROMYCINBrand (NDA)
NDA 050268 · STORZ
- —ACHROMYCIN VBrand (NDA)
NDA 050263 · LEDERLE
- 2020TETRACYCLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212635 · NOVITIUM PHARMA
- 2018TETRACYCLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210662 · BRECKENRIDGE
- 2018TETRACYCLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210674 · AMNEAL PHARMS NY
- 1988TETRACYCLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 062752 · CHARTWELL TETRA
- 1986TETRACYCLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 062686 · PVT FORM
- 1985TETRACYCLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 062540 · SUPERPHARM
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.

