Selegiline Oral Tablet
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Apotex Corp (2012-07-11)
- Oldest Current Product
- 1997-07-06
- License(s)
- ANDA
- RxNORM
- ORAL TABLET\SELEGILINE
- FDAOB
- ORAL\TABLET\SELEGILINE HYDROCHLORIDE
- SPL Active
- ORAL\TABLET\SELEGILINE HYDROCHLORIDE
- SPL Moiety
- ORAL\TABLET\SELEGILINE
product(s) by strength(s)
selegiline hydrochloride 5 mg oral tablet
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 003789290 | ANDA | Mylan Pharmaceuticals Inc. | 2010-03-08 | SELEGILINE HYDROCHLORIDE | ORAL | TABLET | ANDA074866 | 438207da-aff2-4e6e-8ef3-13b35295bea4 |
| 2 | 518620146 | ANDA | Libertas Pharma, Inc. | 2014-05-24 | SELEGILINE HYDROCHLORIDE | ORAL | TABLET | ANDA074912 | ea090c94-1e09-4771-98d7-4f3444650a7d |
| 3 | 605053438 | ANDA | Apotex Corp | 1997-07-06 | SELEGILINE HYDROCHLORIDE | ORAL | TABLET | ANDA074871 | 2aa9f8ee-6a86-6cf1-bec7-6a1ffa5e1ae2 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 604290176 | ANDA | Golden State Medical Supply, Inc. | 2013-04-02 | SELEGILINE HYDROCHLORIDE | ORAL | TABLET | 605053438 | ANDA074871 | 040a97e5-efd1-4a2f-b737-2f13e5366d70 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA074537 | SELEGILINE HYDROCHLORIDE | True | G AND W LABORATORIES INC | 1996-08-02 | ANDA074537_001 |
| 2 | ANDA074565 | SELEGILINE HYDROCHLORIDE | True | VINTAGE PHARMACEUTICALS LLC | 1996-08-02 | ANDA074565_001 |
| 3 | ANDA074641 | SELEGILINE HYDROCHLORIDE | True | DAVA PHARMACEUTICALS INC | 1996-08-02 | ANDA074641_001 |
| 4 | ANDA074672 | SELEGILINE HYDROCHLORIDE | True | SIEGFRIED LTD | 1997-04-01 | ANDA074672_001 |
| 5 | ANDA074744 | SELEGILINE HYDROCHLORIDE | True | G AND W LABORATORIES INC | 1997-01-27 | ANDA074744_001 |
| 6 | ANDA074756 | SELEGILINE HYDROCHLORIDE | True | G AND W LABORATORIES INC | 1998-11-25 | ANDA074756_001 |
| 7 | ANDA074866 | SELEGILINE HYDROCHLORIDE | MYLAN PHARMACEUTICALS INC | 1997-11-26 | ANDA074866_001 | |
| 8 | ANDA074871 | SELEGILINE HYDROCHLORIDE | APOTEX INC ETOBICOKE SITE | 1997-06-06 | ANDA074871_001 | |
| 9 | ANDA074912 | SELEGILINE HYDROCHLORIDE | STASON INDUSTRIAL CORP | 1998-04-30 | ANDA074912_001 | |
| 10 | NDA019334 | SELEGILINE HYDROCHLORIDE | True | SOMERSET PHARMACEUTICALS INC | 1989-06-05 | NDA019334_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA074537_001 | discontinued | SELEGILINE HYDROCHLORIDE (5MG) | ORAL | TABLET | False | 1996-08-02 | SELEGILINE HYDROCHLORIDE | |
| 2 | ANDA074565_001 | discontinued | SELEGILINE HYDROCHLORIDE (5MG) | ORAL | TABLET | False | 1996-08-02 | SELEGILINE HYDROCHLORIDE | |
| 3 | ANDA074641_001 | discontinued | SELEGILINE HYDROCHLORIDE (5MG) | ORAL | TABLET | False | 1996-08-02 | SELEGILINE HYDROCHLORIDE | |
| 4 | ANDA074672_001 | discontinued | SELEGILINE HYDROCHLORIDE (5MG) | ORAL | TABLET | False | 1997-04-01 | SELEGILINE HYDROCHLORIDE | |
| 5 | ANDA074744_001 | discontinued | SELEGILINE HYDROCHLORIDE (5MG) | ORAL | TABLET | False | 1997-01-27 | SELEGILINE HYDROCHLORIDE | |
| 6 | ANDA074756_001 | discontinued | SELEGILINE HYDROCHLORIDE (5MG) | ORAL | TABLET | False | 1998-11-25 | SELEGILINE HYDROCHLORIDE | |
| 7 | ANDA074866_001 | RX | SELEGILINE HYDROCHLORIDE (5MG) | ORAL | TABLET | False | AB | 1997-11-26 | SELEGILINE HYDROCHLORIDE |
| 8 | ANDA074871_001 | RX | SELEGILINE HYDROCHLORIDE (5MG) | ORAL | TABLET | True | AB | 1997-06-06 | SELEGILINE HYDROCHLORIDE |
| 9 | ANDA074912_001 | RX | SELEGILINE HYDROCHLORIDE (5MG) | ORAL | TABLET | False | AB | 1998-04-30 | SELEGILINE HYDROCHLORIDE |
| 10 | NDA019334_001 | discontinued | SELEGILINE HYDROCHLORIDE (5MG) | ORAL | TABLET | False | 1989-06-05 | SELEGILINE HYDROCHLORIDE |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 040a97e5-efd1-4a2f-b737-2f13e5366d70 (view SPL) | Selegiline Hydrochloride Tablets USP 5 mg | prescription | Human Prescription | Golden State Medical Supply, Inc. | RELABEL, REPACK | 2013-12-31 | 2 | 604290176 |
| 2 | 2aa9f8ee-6a86-6cf1-bec7-6a1ffa5e1ae2 (view SPL) | Selegiline Hydrochloride Tablets USP 5 mg | prescription | Human Prescription | Apotex Corp | analysis, manufacture | 2012-07-11 | 2 | 605053438 |
| 3 | 438207da-aff2-4e6e-8ef3-13b35295bea4 (view SPL) | prescription | Human Prescription | Mylan Pharmaceuticals Inc. | 2009-11-26 | 8 | 003789290 | ||
| 4 | ea090c94-1e09-4771-98d7-4f3444650a7d (view SPL) | SELEGILINE HYDROCHLORIDE TABLETS USP 5 MG | prescription | Human Prescription | Libertas Pharma, Inc. | 2014-05-20 | 1 | 518620146 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII