Application 212286
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | SYRUP;ORAL | 10MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0622 | Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 17856-0623 | Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 17856-0623 | Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 17856-0623 | Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 70518-3220 | Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63448 | ORIG | 2020-06-08 |