FDA Orange Book · active-ingredient family
Temazepam
Temazepam is approved as 1 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RESTORIL · NDA 018163
1
Brand (NDA)
23
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RESTORILRLD×4 | SPECGX LLC | NDA 018163 | AB | Oct 25, 1991 |
Generic (ANDA) products (23)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TEMAZEPAM×4 | ALKEM LABS LTD | ANDA 217875 | AB | Aug 24, 2023 | |
| TEMAZEPAM×4 | ALEMBIC | ANDA 211542 | AB | Nov 23, 2018 | |
| TEMAZEPAM×4 | AMNEAL PHARMS | ANDA 203482 | AB | May 23, 2016 | |
| TEMAZEPAM×4 | PRINSTON INC | ANDA 201781 | AB | Jun 04, 2015 | |
| TEMAZEPAM×3 | NOVEL LABS INC | ANDA 071457 | AB | Jun 22, 2012 | |
| TEMAZEPAM×4 | AUROBINDO PHARMA USA | ANDA 070920 | — | May 21, 2010 | |
| TEMAZEPAM×2 | SUN PHARM INDUSTRIES | ANDA 071175 | — | Sep 14, 2009 | |
| TEMAZEPAM | SUN PHARM INDUSTRIES | ANDA 078581 | — | Sep 08, 2009 | |
| TEMAZEPAM | WATSON LABS | ANDA 071446 | — | May 21, 1993 | |
| TEMAZEPAM | WATSON LABS | ANDA 071447 | — | May 21, 1993 | |
| TEMAZEPAM | DURAMED PHARMS BARR | ANDA 071708 | — | Sep 29, 1988 | |
| TEMAZEPAM | DURAMED PHARMS BARR | ANDA 071709 | — | Sep 29, 1988 | |
| TEMAZEPAM | CHARTWELL RX | ANDA 071427 | AB | Jan 12, 1988 | |
| TEMAZEPAM | CHARTWELL RX | ANDA 071428 | AB | Jan 12, 1988 | |
| TEMAZEPAM×2 | ACTAVIS ELIZABETH | ANDA 071620 | AB | Aug 07, 1987 | |
| TEMAZEPAM | NOVEL LABS INC | ANDA 071456 | AB | Apr 21, 1987 | |
| TEMAZEPAM | WATSON LABS | ANDA 070383 | — | Mar 23, 1987 | |
| TEMAZEPAM | WATSON LABS | ANDA 070384 | — | Mar 23, 1987 | |
| TEMAZEPAM | SUN PHARM INDUSTRIES | ANDA 071174 | — | Jul 10, 1986 | |
| TEMAZEPAM | USL PHARMA | ANDA 070489 | — | Jul 07, 1986 | |
| TEMAZEPAM | USL PHARMA | ANDA 070490 | — | Jul 07, 1986 | |
| TEMAZ | QUANTUM PHARMICS | ANDA 070564 | — | Oct 15, 1985 | |
| TEMAZ | QUANTUM PHARMICS | ANDA 070547 | — | Oct 15, 1985 |
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.
Temazepam — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
