FDA Orange Book · active-ingredient family
Atropine sulfate; meperidine hydrochloride
Atropine sulfate; meperidine hydrochloride is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATROPINE AND DEMEROL | ABBVIE | ANDA 087853 | — | Nov 26, 1982 | |
| ATROPINE AND DEMEROL | ABBVIE | ANDA 087847 | — | Nov 26, 1982 | |
| ATROPINE AND DEMEROL | ABBVIE | ANDA 087848 | — | Nov 26, 1982 | |
| MEPERIDINE AND ATROPINE SULFATE×3 | WYETH AYERST | ANDA 085121 | — | 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.
Atropine sulfate; meperidine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
