FDA Orange Book · active-ingredient family
Ergocalciferol
Ergocalciferol is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DRISDOL · NDA 003444
1
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DRISDOLRLD | ESJAY PHARMA | NDA 003444 | AA | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERGOCALCIFEROL | PURACAP PHARM LLC | ANDA 204276 | AA | Dec 07, 2018 | |
| ERGOCALCIFEROL | ONESOURCE SPECIALTY | ANDA 090455 | AA | Aug 03, 2010 | |
| ERGOCALCIFEROL | SIGMAPHARM LABS LLC | ANDA 091004 | — | Jul 14, 2010 | |
| ERGOCALCIFEROL | SUN PHARM INDS INC | ANDA 040865 | — | Dec 29, 2009 | |
| ERGOCALCIFEROL | CHARTWELL RX | ANDA 040833 | AA | May 20, 2009 | |
| DELTALIN | LILLY | ANDA 080884 | — | Approved Prior to Jan 1, 1982 | |
| VITAMIN D | BIONPHARMA | ANDA 080704 | AA | Approved Prior to Jan 1, 1982 | |
| VITAMIN D | CHARTWELL MOLECULAR | ANDA 080825 | — | Approved Prior to Jan 1, 1982 | |
| VITAMIN D | CHASE CHEM | ANDA 080747 | — | Approved Prior to Jan 1, 1982 | |
| VITAMIN D | EVERYLIFE | ANDA 080956 | — | Approved Prior to Jan 1, 1982 | |
| VITAMIN D | IMPAX LABS | ANDA 080951 | — | Approved Prior to Jan 1, 1982 | |
| VITAMIN D | VITARINE | ANDA 084053 | — | Approved Prior to Jan 1, 1982 | |
| VITAMIN D | WEST WARD | ANDA 083102 | — | 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.
Ergocalciferol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
