Amantadine Oral Tablet
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Upsher-Smith Laboratories, Inc. (2014-10-22)
- Oldest Current Product
- 2011-12-15
- License(s)
- ANDA
- RxNORM
- ORAL TABLET\AMANTADINE
- FDAOB
- ORAL\TABLET\AMANTADINE HYDROCHLORIDE
- SPL Active
- ORAL\TABLET\AMANTADINE HYDROCHLORIDE
- SPL Moiety
- ORAL\TABLET\AMANTADINE
product(s) by strength(s)
amantadine hydrochloride 100 mg oral tablet
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 008320111 | ANDA | Upsher-Smith Laboratories, Inc. | 2011-12-15 | AMANTADINE HYDROCHLORIDE | ORAL | TABLET | ANDA076186 | 63d9d4aa-5f92-45b0-98d0-d6ec38b727cb |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA076186 | AMANTADINE HYDROCHLORIDE | USL PHARMA INC | 2002-12-16 | ANDA076186_001 | |
| 2 | NDA018101 | SYMMETREL | True | ENDO PHARMACEUTICALS INC | NDA018101_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA076186_001 | RX | AMANTADINE HYDROCHLORIDE (100MG) | ORAL | TABLET | True | 2002-12-16 | AMANTADINE HYDROCHLORIDE |
| 2 | NDA018101_001 | discontinued | AMANTADINE HYDROCHLORIDE (100MG) | ORAL | TABLET | False | SYMMETREL |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 63d9d4aa-5f92-45b0-98d0-d6ec38b727cb (view SPL) | Amantadine HCl Tablets | prescription | Human Prescription | Upsher-Smith Laboratories, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2014-10-22 | 3 | 008320111 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII