58602-816-83 |
58602-816 |
HUMAN OTC DRUG |
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold |
Naproxen Sodium and Pseudoephedrine Hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20220601 |
N/A |
ANDA |
ANDA211360 |
Aurohealth LLC |
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE |
220 mg/1; 120 mg/1 |
1 BLISTER PACK in 1 CARTON (58602-816-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
58602-816-67 |
58602-816 |
HUMAN OTC DRUG |
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold |
Naproxen Sodium and Pseudoephedrine Hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20220601 |
N/A |
ANDA |
ANDA211360 |
Aurohealth LLC |
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE |
220 mg/1; 120 mg/1 |
2 BLISTER PACK in 1 CARTON (58602-816-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
58602-832-83 |
58602-832 |
HUMAN OTC DRUG |
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache |
Naproxen Sodium and Pseudoephedrine Hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20220601 |
N/A |
ANDA |
ANDA211360 |
Aurohealth LLC |
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE |
220 mg/1; 120 mg/1 |
1 BLISTER PACK in 1 CARTON (58602-832-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
58602-832-67 |
58602-832 |
HUMAN OTC DRUG |
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache |
Naproxen Sodium and Pseudoephedrine Hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20220601 |
N/A |
ANDA |
ANDA211360 |
Aurohealth LLC |
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE |
220 mg/1; 120 mg/1 |
2 BLISTER PACK in 1 CARTON (58602-832-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
71179-816-24 |
71179-816 |
HUMAN OTC DRUG |
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS |
Naproxen Sodium and Pseudoephedrine Hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20240807 |
N/A |
ANDA |
ANDA211360 |
VESPYR BRANDS, INC. |
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE |
220 mg/1; 120 mg/1 |
3 BLISTER PACK in 1 CARTON (71179-816-24) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |