0280-0065-01 |
0280-0065 |
HUMAN OTC DRUG |
Astepro Allergy |
Azelastine HCl |
SPRAY, METERED |
NASAL |
20220705 |
N/A |
NDA |
NDA213872 |
Bayer HealthCare LLC. |
AZELASTINE HYDROCHLORIDE |
205.5 ug/1 |
60 CARTON in 1 BOTTLE (0280-0065-01) / 1 SPRAY, METERED in 1 CARTON |
0280-0065-02 |
0280-0065 |
HUMAN OTC DRUG |
Astepro Allergy |
Azelastine HCl |
SPRAY, METERED |
NASAL |
20220705 |
N/A |
NDA |
NDA213872 |
Bayer HealthCare LLC. |
AZELASTINE HYDROCHLORIDE |
205.5 ug/1 |
120 CARTON in 1 BOTTLE (0280-0065-02) / 1 SPRAY, METERED in 1 CARTON |
0280-0065-03 |
0280-0065 |
HUMAN OTC DRUG |
Astepro Allergy |
Azelastine HCl |
SPRAY, METERED |
NASAL |
20220705 |
N/A |
NDA |
NDA213872 |
Bayer HealthCare LLC. |
AZELASTINE HYDROCHLORIDE |
205.5 ug/1 |
120 PACKAGE in 1 BOTTLE (0280-0065-03) / 3 SPRAY, METERED in 1 PACKAGE |
0280-0065-04 |
0280-0065 |
HUMAN OTC DRUG |
Astepro Allergy |
Azelastine HCl |
SPRAY, METERED |
NASAL |
20220705 |
N/A |
NDA |
NDA213872 |
Bayer HealthCare LLC. |
AZELASTINE HYDROCHLORIDE |
205.5 ug/1 |
200 CARTON in 1 BOTTLE (0280-0065-04) / 1 SPRAY, METERED in 1 CARTON |
0280-0065-05 |
0280-0065 |
HUMAN OTC DRUG |
Astepro Allergy |
Azelastine HCl |
SPRAY, METERED |
NASAL |
20230124 |
N/A |
NDA |
NDA213872 |
Bayer HealthCare LLC. |
AZELASTINE HYDROCHLORIDE |
205.5 ug/1 |
22 CARTON in 1 BOTTLE (0280-0065-05) / 1 SPRAY, METERED in 1 CARTON |
0280-0065-09 |
0280-0065 |
HUMAN OTC DRUG |
Astepro Allergy |
Azelastine HCl |
SPRAY, METERED |
NASAL |
20220705 |
N/A |
NDA |
NDA213872 |
Bayer HealthCare LLC. |
AZELASTINE HYDROCHLORIDE |
205.5 ug/1 |
120 CARTON in 1 BOTTLE (0280-0065-09) / 2 SPRAY, METERED in 1 CARTON |
0280-0065-10 |
0280-0065 |
HUMAN OTC DRUG |
Astepro Allergy |
Azelastine HCl |
SPRAY, METERED |
NASAL |
20220705 |
N/A |
NDA |
NDA213872 |
Bayer HealthCare LLC. |
AZELASTINE HYDROCHLORIDE |
205.5 ug/1 |
22 CARTON in 1 BOTTLE (0280-0065-10) / 1 SPRAY, METERED in 1 CARTON |
0280-0066-03 |
0280-0066 |
HUMAN OTC DRUG |
Children Astepro Allergy |
Azelastine HCl |
SPRAY, METERED |
NASAL |
20220630 |
N/A |
NDA |
NDA213872 |
Bayer HealthCare LLC. |
AZELASTINE HYDROCHLORIDE |
205.5 ug/1 |
22 CARTON in 1 BOTTLE (0280-0066-03) / 1 SPRAY, METERED in 1 CARTON |
0280-0066-02 |
0280-0066 |
HUMAN OTC DRUG |
Children Astepro Allergy |
Azelastine HCl |
SPRAY, METERED |
NASAL |
20220630 |
N/A |
NDA |
NDA213872 |
Bayer HealthCare LLC. |
AZELASTINE HYDROCHLORIDE |
205.5 ug/1 |
120 CARTON in 1 BOTTLE (0280-0066-02) / 1 SPRAY, METERED in 1 CARTON |
0280-0066-01 |
0280-0066 |
HUMAN OTC DRUG |
Children Astepro Allergy |
Azelastine HCl |
SPRAY, METERED |
NASAL |
20220630 |
N/A |
NDA |
NDA213872 |
Bayer HealthCare LLC. |
AZELASTINE HYDROCHLORIDE |
205.5 ug/1 |
60 CARTON in 1 BOTTLE (0280-0066-01) / 1 SPRAY, METERED in 1 CARTON |