FDA Orange Book · active-ingredient family
Procaine hydrochloride; tetracycline hydrochloride
Procaine hydrochloride; tetracycline hydrochloride is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ACHROMYCIN · NDA 050276
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACHROMYCIN×2 | LEDERLE | NDA 050276 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TETRACYN×2 | PFIZER | ANDA 060285 | — | Approved Prior to Jan 1, 1982 |
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.
Procaine hydrochloride; tetracycline hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
