FDA Orange Book · active-ingredient family
Glycine
Glycine is approved in 5 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER · NDA 017865
5
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMINOACETIC ACID 1.5% IN PLASTIC CONTAINERRLD | BAXTER HLTHCARE | NDA 017865 | AT | Approved Prior to Jan 1, 1982 | |
| GLYCINE 1.5% IN PLASTIC CONTAINER | BAXTER HLTHCARE | NDA 018522 | — | Feb 19, 1982 | |
| GLYCINE 1.5% IN PLASTIC CONTAINER | B BRAUN | NDA 016784 | AT | Approved Prior to Jan 1, 1982 | |
| GLYCINE 1.5% IN PLASTIC CONTAINER | HOSPIRA | NDA 017633 | — | Approved Prior to Jan 1, 1982 | |
| GLYCINE 1.5% IN PLASTIC CONTAINER | OTSUKA ICU MEDCL | NDA 018315 | AT | 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.
Glycine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
