17856-0172-4 |
17856-0172 |
HUMAN OTC DRUG |
Delsym |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20240419 |
N/A |
NDA |
NDA018658 |
ATLANTIC BIOLOGICALS CORP. |
DEXTROMETHORPHAN |
30 mg/5mL |
1 BOX, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0172-4) / 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0172-1) / 10 mL in 1 CUP, UNIT-DOSE |
17856-0172-3 |
17856-0172 |
HUMAN OTC DRUG |
Delsym |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20240419 |
N/A |
NDA |
NDA018658 |
ATLANTIC BIOLOGICALS CORP. |
DEXTROMETHORPHAN |
30 mg/5mL |
1 BOX, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0172-3) / 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0172-2) / 5 mL in 1 CUP, UNIT-DOSE |
63824-171-63 |
63824-171 |
HUMAN OTC DRUG |
Delsym |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20100504 |
N/A |
NDA |
NDA018658 |
RB Health (US) LLC |
DEXTROMETHORPHAN |
30 mg/5mL |
1 BOTTLE in 1 CARTON (63824-171-63) / 89 mL in 1 BOTTLE |
63824-173-63 |
63824-173 |
HUMAN OTC DRUG |
Delsym (Dextromethorphan) |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20110819 |
N/A |
NDA |
NDA018658 |
RB Health (US) LLC |
DEXTROMETHORPHAN |
30 mg/5mL |
1 BOTTLE in 1 CARTON (63824-173-63) / 89 mL in 1 BOTTLE |
63824-173-65 |
63824-173 |
HUMAN OTC DRUG |
Delsym (Dextromethorphan) |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20110819 |
N/A |
NDA |
NDA018658 |
RB Health (US) LLC |
DEXTROMETHORPHAN |
30 mg/5mL |
1 BOTTLE in 1 CARTON (63824-173-65) / 148 mL in 1 BOTTLE |
63824-171-22 |
63824-171 |
HUMAN OTC DRUG |
Delsym |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20100504 |
N/A |
NDA |
NDA018658 |
RB Health (US) LLC |
DEXTROMETHORPHAN |
30 mg/5mL |
2 CARTON in 1 CELLO PACK (63824-171-22) / 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE |
63824-171-65 |
63824-171 |
HUMAN OTC DRUG |
Delsym |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20100504 |
N/A |
NDA |
NDA018658 |
RB Health (US) LLC |
DEXTROMETHORPHAN |
30 mg/5mL |
1 BOTTLE in 1 CARTON (63824-171-65) / 148 mL in 1 BOTTLE |
63824-171-75 |
63824-171 |
HUMAN OTC DRUG |
Delsym |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20100504 |
N/A |
NDA |
NDA018658 |
RB Health (US) LLC |
DEXTROMETHORPHAN |
30 mg/5mL |
1 BOTTLE in 1 CARTON (63824-171-75) / 15 mL in 1 BOTTLE |
63824-175-22 |
63824-175 |
HUMAN OTC DRUG |
Delsym |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20100504 |
N/A |
NDA |
NDA018658 |
RB Health (US) LLC |
DEXTROMETHORPHAN |
30 mg/5mL |
2 CARTON in 1 CELLO PACK (63824-175-22) / 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE |
63824-177-63 |
63824-177 |
HUMAN OTC DRUG |
Delsym (Dextromethorphan) |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20110819 |
N/A |
NDA |
NDA018658 |
RB Health (US) LLC |
DEXTROMETHORPHAN |
30 mg/5mL |
1 BOTTLE in 1 CARTON (63824-177-63) / 89 mL in 1 BOTTLE |
63824-177-65 |
63824-177 |
HUMAN OTC DRUG |
Delsym (Dextromethorphan) |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20170701 |
20241003 |
NDA |
NDA018658 |
RB Health (US) LLC |
DEXTROMETHORPHAN |
30 mg/5mL |
1 BOTTLE in 1 CARTON (63824-177-65) / 148 mL in 1 BOTTLE |
63824-175-63 |
63824-175 |
HUMAN OTC DRUG |
Delsym |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20100504 |
N/A |
NDA |
NDA018658 |
RB Health (US) LLC |
DEXTROMETHORPHAN |
30 mg/5mL |
1 BOTTLE in 1 CARTON (63824-175-63) / 89 mL in 1 BOTTLE |
63824-175-65 |
63824-175 |
HUMAN OTC DRUG |
Delsym |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20100504 |
N/A |
NDA |
NDA018658 |
RB Health (US) LLC |
DEXTROMETHORPHAN |
30 mg/5mL |
1 BOTTLE in 1 CARTON (63824-175-65) / 148 mL in 1 BOTTLE |
63824-175-75 |
63824-175 |
HUMAN OTC DRUG |
Delsym |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20100504 |
N/A |
NDA |
NDA018658 |
RB Health (US) LLC |
DEXTROMETHORPHAN |
30 mg/5mL |
1 BOTTLE in 1 CARTON (63824-175-75) / 15 mL in 1 BOTTLE |
50090-0224-0 |
50090-0224 |
HUMAN OTC DRUG |
DELSYM |
Dextromethorphan |
SUSPENSION, EXTENDED RELEASE |
ORAL |
20141128 |
N/A |
NDA |
NDA018658 |
A-S Medication Solutions |
DEXTROMETHORPHAN |
30 mg/5mL |
1 BOTTLE in 1 CARTON (50090-0224-0) / 89 mL in 1 BOTTLE |