| Application No | Product No | Proprietary Name | Active Ingredient | Dosage Form;Route | Strength | Company | Approval Date | RLD | Marketing Status | TE Code |
|---|---|---|---|---|---|---|---|---|---|---|
| (ANDA) 215028 | 001 | ETOMIDATE | ETOMIDATE | INJECTABLE;INJECTION | 2MG/ML | CAPLIN | 2020-12-18 | No | RX | AP |
| (ANDA) 214879 | 001 | SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | INJECTABLE;INJECTION | 20MG/ML | MICRO LABS | 2020-11-24 | No | RX | AP |
| (ANDA) 214839 | 001 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 10,000 UNITS/ML | BE PHARMS | 2020-12-29 | No | RX | AP |
| (ANDA) 214804 | 001 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 1,000 UNITS/ML | BE PHARMS | 2020-12-29 | No | RX | AP |
| (ANDA) 214803 | 001 | LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | TABLET;ORAL | EQ 0.005MG BASE | ZYDUS | 2021-01-22 | No | RX | AB |
| (ANDA) 214803 | 002 | LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | TABLET;ORAL | EQ 0.025MG BASE | ZYDUS | 2021-01-22 | No | RX | AB |
| (ANDA) 214803 | 003 | LIOTHYRONINE SODIUM | LIOTHYRONINE SODIUM | TABLET;ORAL | EQ 0.05MG BASE | ZYDUS | 2021-01-22 | No | RX | AB |
| (NDA) 214787 | 001 | VEKLURYP | REMDESIVIR | POWDER;INTRAVENOUS | 100MG/VIAL | GILEAD SCIENCES INC | 2020-10-22 | Yes | RX | |
| (NDA) 214787 | 002 | VEKLURYP | REMDESIVIR | SOLUTION;INTRAVENOUS | 100MG/20ML (5MG/ML) | GILEAD SCIENCES INC | 2020-10-22 | Yes | RX | |
| (ANDA) 214785 | 001 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.4MG/ML | BAXTER HLTHCARE CORP | 2021-01-29 | No | RX | AP |
| (ANDA) 214766 | 001 | FUROSEMIDE | FUROSEMIDE | INJECTABLE;INJECTION | 10MG/ML | ATHENEX INC | 2021-01-27 | No | RX | AP |
| (ANDA) 214734 | 001 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | TABLET;ORAL | 2.5MG | ALEMBIC PHARMS LTD | 2021-01-21 | No | RX | AB |
| (ANDA) 214734 | 002 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | TABLET;ORAL | 5MG | ALEMBIC PHARMS LTD | 2021-01-21 | No | RX | AB |
| (ANDA) 214734 | 003 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | TABLET;ORAL | 10MG | ALEMBIC PHARMS LTD | 2021-01-21 | No | RX | AB |
| (ANDA) 214684 | 001 | LORATADINE | LORATADINE | TABLET;ORAL | 10MG | UNIQUE PHARM | 2021-01-07 | No | OTC | |
| (NDA) 214652 | 001 | ATROPINE SULFATE | ATROPINE SULFATE | SOLUTION;INTRAVENOUS | 0.4MG/ML (0.4MG/ML) | ACCORD HLTHCARE | 2020-09-29 | Yes | RX | |
| (NDA) 214652 | 002 | ATROPINE SULFATE | ATROPINE SULFATE | SOLUTION;INTRAVENOUS | 1MG/ML (1MG/ML) | ACCORD HLTHCARE | 2020-09-29 | Yes | RX | |
| (NDA) 214621 | 001 | ORGOVYXP | RELUGOLIX | TABLET;ORAL | 120MG | MYOVANT SCIENCES | 2020-12-18 | Yes | RX | |
| (ANDA) 214603 | 001 | GEMFIBROZIL | GEMFIBROZIL | TABLET;ORAL | 600MG | ASCENT PHARMS INC | 2021-01-13 | No | RX | AB |
| (ANDA) 214574 | 001 | AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | TABLET;ORAL | 5MG | SUN PHARM INDS INC | 2021-01-27 | No | RX | AA |