Register entryShortage reported
Azurity Pharmaceuticals, Inc.
- Registered sites
- 0
- Drug products
- 62
- Live patents
- 199
- Countries
- 0
- Base
- Unknown
Sites
Facilities
0No registered facilities
This company holds drug listings or approvals but operates no registered establishment of its own, which is normal for an NDA holder that outsources manufacturing.
Alert
Products in shortage
4| Drug | Presentation | Availability |
|---|---|---|
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08) | Available |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 72572-127-10) | Available |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 200 mcg/50 mL (4 ug/1 mL) (NDC 52536-125-10) | Available |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 52536-126-08) | Available |
Exclusivity
Patents
199Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ALVESCO | CICLESONIDE | Feb 2028 |
| ARYNTA | LISDEXAMFETAMINE DIMESYLATE | Apr 2040 |
| ARYNTA | LISDEXAMFETAMINE DIMESYLATE | Aug 2040 |
| AZMIRO | TESTOSTERONE CYPIONATE | Mar 2039 |
| BRYNOVIN | SITAGLIPTIN HYDROCHLORIDE | Oct 2040 |
| CONTRAVE | BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE | Jun 2027 |
| CONTRAVE | BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE | Nov 2027 |
| CONTRAVE | BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE | Feb 2029 |
| CONTRAVE | BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE | May 2029 |
| CONTRAVE | BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE | Feb 2030 |
| CONTRAVE | BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE | Jan 2031 |
| CONTRAVE | BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE | Jan 2032 |
| CONTRAVE | BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE | Jun 2033 |
| CONTRAVE | BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE | Jun 2033 |
| CONTRAVE | BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE | Jul 2034 |
| DANZITEN | NILOTINIB TARTRATE | Feb 2040 |
| DUAKLIR PRESSAIR | ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE | Mar 2029 |
| EDARBI | AZILSARTAN KAMEDOXOMIL | Mar 2028 |
| EDARBYCLOR | AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE | Mar 2028 |
| EDARBYCLOR | AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE | Feb 2030 |
| EDARBYCLOR | AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE | Jul 2031 |
| EPANED | ENALAPRIL MALEATE | Mar 2036 |
| EPANED KIT | ENALAPRIL MALEATE | Nov 2032 |
| EPRONTIA | TOPIRAMATE | Aug 2040 |
| EVEKEO ODT | AMPHETAMINE SULFATE | Mar 2037 |
| FIRVANQ KIT | VANCOMYCIN HYDROCHLORIDE | Mar 2035 |
| FLEQSUVY | BACLOFEN | Sept 2037 |
| FLEQSUVY | BACLOFEN | Sept 2037 |
| HORIZANT | GABAPENTIN ENACARBIL | Nov 2026 |
| HORIZANT | GABAPENTIN ENACARBIL | Jun 2029 |
| JAVADIN | CLONIDINE HYDROCHLORIDE | Jul 2042 |
| KATERZIA | AMLODIPINE BENZOATE | Oct 2037 |
| KATERZIA | AMLODIPINE BENZOATE | Oct 2037 |
| KATERZIA | AMLODIPINE BENZOATE | Apr 2039 |
| KONVOMEP | OMEPRAZOLE; SODIUM BICARBONATE | Jul 2039 |
| KONVOMEP | OMEPRAZOLE; SODIUM BICARBONATE | Mar 2040 |
| MYHIBBIN | MYCOPHENOLATE MOFETIL | Aug 2039 |
| NYMALIZE | NIMODIPINE | Apr 2038 |
| OMNARIS | CICLESONIDE | Feb 2028 |
| ONZETRA XSAIL | SUMATRIPTAN SUCCINATE | Mar 2027 |
| ONZETRA XSAIL | SUMATRIPTAN SUCCINATE | Dec 2027 |
| ONZETRA XSAIL | SUMATRIPTAN SUCCINATE | Apr 2028 |
| ONZETRA XSAIL | SUMATRIPTAN SUCCINATE | Dec 2028 |
| ONZETRA XSAIL | SUMATRIPTAN SUCCINATE | Jul 2029 |
| ONZETRA XSAIL | SUMATRIPTAN SUCCINATE | Oct 2029 |
| ONZETRA XSAIL | SUMATRIPTAN SUCCINATE | Aug 2030 |
| ONZETRA XSAIL | SUMATRIPTAN SUCCINATE | Oct 2030 |
| ONZETRA XSAIL | SUMATRIPTAN SUCCINATE | Dec 2030 |
| ONZETRA XSAIL | SUMATRIPTAN SUCCINATE | Nov 2033 |
| ONZETRA XSAIL | SUMATRIPTAN SUCCINATE | Oct 2034 |
| PREVDUO | GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE | Oct 2038 |
| QBRELIS | LISINOPRIL | Nov 2035 |
| SOTYLIZE | SOTALOL HYDROCHLORIDE | Apr 2034 |
| SOTYLIZE | SOTALOL HYDROCHLORIDE | Nov 2034 |
| SOTYLIZE | SOTALOL HYDROCHLORIDE | Aug 2035 |
| SUFLAVE | MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE | Jun 2044 |
| SUFLAVE | MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE | Aug 2044 |
| SUTAB | MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE | Aug 2037 |
| TRIPTODUR KIT | TRIPTORELIN PAMOATE | Jun 2029 |
| TUDORZA PRESSAIR | ACLIDINIUM BROMIDE | Mar 2029 |
Catalogue
Marketed products
62Showing 62 of 62.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ARYNTA | lisdexamfetamine dimesylate oral | SOLUTION | NDA |
| ARYNTA | lisdexamfetamine dimesylate oral | SOLUTION | NDA |
| ARYNTA | lisdexamfetamine dimesylate oral | SOLUTION | NDA |
| ARYNTA | lisdexamfetamine dimesylate oral | SOLUTION | NDA |
| ARYNTA | lisdexamfetamine dimesylate oral | SOLUTION | NDA |
| AZMIRO | TESTOSTERONE CYPIONATE | INJECTION, SOLUTION | NDA |
| AZMIRO | TESTOSTERONE CYPIONATE | INJECTION, SOLUTION | NDA |
| BRYNOVIN | Sitagliptin Hydrochloride Oral | SOLUTION | NDA |
| BiDil | Hydralazine hydrochloride and Isosorbide dinitrate | TABLET, FILM COATED | NDA |
| DANZITEN | nilotinib | TABLET | NDA |
| DANZITEN | nilotinib | TABLET | NDA |
| - | Diphenhydramine Hydrochloride and Lidocaine Hydrochloride and Aluminum Hydroxide and Magnesium Hydro | KIT | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| Edarbi | Azilsartan kamedoxomil | TABLET | NDA |
| Edarbi | Azilsartan kamedoxomil | TABLET | NDA |
| Epaned | enalapril maleate | SOLUTION | NDA |
| Eprontia | Topiramate | SOLUTION | NDA |
| Evekeo | Amphetamine Sulfate | TABLET | ANDA |
| Evekeo | Amphetamine Sulfate | TABLET | ANDA |
| FIRVANQ | vancomycin hydrochloride | KIT | NDA |
| FIRVANQ | vancomycin hydrochloride | KIT | NDA |
| FIRVANQ | vancomycin hydrochloride | KIT | NDA |
| FIRVANQ | vancomycin hydrochloride | KIT | NDA |
| FLEQSUVY | baclofen | SUSPENSION | NDA |
| FeraBright | Ferumoxytol | INJECTION | NDA |
| FeraBright | Ferumoxytol | INJECTION | NDA |
| Gleostine | lomustine | CAPSULE, GELATIN COATED | NDA |
| Gleostine | lomustine | CAPSULE, GELATIN COATED | NDA |
| Gleostine | lomustine | CAPSULE, GELATIN COATED | NDA |
| Gliadel | carmustine | WAFER | NDA |
| GoLYTELY | Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride | POWDER, FOR SOLUTION | NDA |
| Ivermectin | Ivermectin | LOTION | ANDA |
| JAVADIN | clonidine hydrochloride oral | SOLUTION | NDA |
| Katerzia | Amlodipine | SUSPENSION | NDA |
| Konvomep | omeprazole and sodium bicarbonate | KIT | NDA |
| - | Lansoprazole | KIT | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| MYHIBBIN | MYCOPHENOLATE MOFETIL | SUSPENSION | NDA |
| - | Metronidazole Benzoate | KIT | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| Nymalize | nimodipine | SOLUTION | NDA |
| Nymalize | nimodipine | SOLUTION | NDA |
| - | Omeprazole | KIT | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| Qbrelis | lisinopril | SOLUTION | NDA |
| SOTYLIZE | SOTALOL HYDROCHLORIDE | SOLUTION | NDA |
| SUFLAVE | polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution | KIT | NDA |
| SUPREP Bowel Prep | sodium sulfate, potassium sulfate, magnesium sulfate | SOLUTION, CONCENTRATE | NDA |
| SUPREP Bowel Prep | sodium sulfate, potassium sulfate, magnesium sulfate | SOLUTION, CONCENTRATE | NDA |
| SUTAB | sodium sulfate, magnesium sulfate, and potassium chloride | TABLET | NDA |
| Sklice | ivermectin | LOTION | NDA |
| TRIPTODUR | triptorelin | KIT | NDA |
| VIVIMUSTA | BENDAMUSTINE HYDROCHLORIDE | INJECTION | NDA |
| WIDAPLIK | telmisartan, amlodipine and indapamide | TABLET | NDA |
| WIDAPLIK | telmisartan, amlodipine and indapamide | TABLET | NDA |
| WIDAPLIK | telmisartan, amlodipine and indapamide | TABLET | NDA |
| XIFYRM | meloxicam | INJECTION | NDA |
| Xatmep | Methotrexate | SOLUTION | NDA |
| ZONISADE | ZONISAMIDE | SUSPENSION | NDA |
| Zenzedi | Dextroamphetamine Sulfate | TABLET | ANDA |
| Zenzedi | Dextroamphetamine Sulfate | TABLET | ANDA |
| Zenzedi | Dextroamphetamine Sulfate | TABLET | ANDA |
| Zenzedi | Dextroamphetamine Sulfate | TABLET | ANDA |
| Zenzedi | Dextroamphetamine Sulfate | TABLET | ANDA |
| Zenzedi | Dextroamphetamine Sulfate | TABLET | ANDA |
| Zenzedi | Dextroamphetamine Sulfate | TABLET | ANDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.