Orange Book product · Brand (NDA)
ACHROMYCIN V
TETRACYCLINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
TETRACYCLINE HYDROCHLORIDE
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 050278
Product number
003
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.
- 1994ACTISITEBrand (NDA)
NDA 050653 · SCHIFF AND CO
- —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.
