Amitriptyline / Chlordiazepoxide Oral Tablet
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Mylan Pharmaceuticals Inc. (2014-12-23)
- Oldest Current Product
- 1986-12-10
- License(s)
- ANDA
- RxNORM
- ORAL TABLET\AMITRIPTYLINE:CHLORDIAZEPOXIDE
- FDAOB
- ORAL\TABLET\AMITRIPTYLINE HYDROCHLORIDE: CHLORDIAZEPOXIDE
- SPL Active
- ORAL\TABLET, FILM COATED\AMITRIPTYLINE HYDROCHLORIDE: CHLORDIAZEPOXIDE
ORAL\TABLET\AMITRIPTYLINE HYDROCHLORIDE: CHLORDIAZEPOXIDE - SPL Moiety
- ORAL\TABLET, FILM COATED\AMITRIPTYLINE: CHLORDIAZEPOXIDE
ORAL\TABLET\AMITRIPTYLINE: CHLORDIAZEPOXIDE
product(s) by strength(s)
amitriptyline hydrochloride 12.5 mg / chlordiazepoxide 5 mg oral tablet
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 003780211 | ANDA | Mylan Pharmaceuticals Inc. | 1986-12-10 | AMITRIPTYLINE HYDROCHLORIDE, CHLORDIAZEPOXIDE | ORAL | TABLET, FILM COATED | ANDA071297 | 66a756f2-ac77-451c-a19a-08896d73b15c |
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 498840265 | ANDA | Par Pharmaceutical Companies, Inc. | 1988-05-09 | AMITRIPTYLINE HYDROCHLORIDE, CHLORDIAZEPOXIDE | ORAL | TABLET | ANDA072277 | 22d710ec-302a-4756-95e3-8ee7957586e4 |
amitriptyline hydrochloride 25 mg / chlordiazepoxide 10 mg oral tablet
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 003780277 | ANDA | Mylan Pharmaceuticals Inc. | 1986-12-10 | AMITRIPTYLINE HYDROCHLORIDE, CHLORDIAZEPOXIDE | ORAL | TABLET, FILM COATED | ANDA071297 | 66a756f2-ac77-451c-a19a-08896d73b15c |
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 498840266 | ANDA | Par Pharmaceutical Companies, Inc. | 1988-05-09 | AMITRIPTYLINE HYDROCHLORIDE, CHLORDIAZEPOXIDE | ORAL | TABLET | ANDA072278 | 22d710ec-302a-4756-95e3-8ee7957586e4 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA070477 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | True | USL PHARMA INC | 1988-01-12 | ANDA070477_001 |
| 2 | ANDA070478 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | True | USL PHARMA INC | 1988-01-12 | ANDA070478_001 |
| 3 | ANDA070765 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | True | MUTUAL PHARMACEUTICAL CO INC | 1986-12-10 | ANDA070765_001 |
| 4 | ANDA070766 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | True | MUTUAL PHARMACEUTICAL CO INC | 1986-12-10 | ANDA070766_001 |
| 5 | ANDA071297 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | MYLAN PHARMACEUTICALS INC | 1986-12-10 | ANDA071297_001, ANDA071297_002 | |
| 6 | ANDA072052 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | True | WATSON LABORATORIES INC | 1988-12-16 | ANDA072052_001 |
| 7 | ANDA072053 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | True | WATSON LABORATORIES INC | 1988-12-16 | ANDA072053_001 |
| 8 | ANDA072277 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | True | PAR PHARMACEUTICAL INC | 1988-05-09 | ANDA072277_001 |
| 9 | ANDA072278 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | True | PAR PHARMACEUTICAL INC | 1988-05-09 | ANDA072278_001 |
| 10 | NDA016949 | LIMBITROL | True | HERITAGE PHARMACEUTICALS INC | NDA016949_001, NDA016949_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA070477_001 | discontinued | CHLORDIAZEPOXIDE (5MG), AMITRIPTYLINE HYDROCHLORIDE (EQ 12.5MG BASE) | ORAL | TABLET | False | 1988-01-12 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE |
| 2 | ANDA070478_001 | discontinued | CHLORDIAZEPOXIDE (10MG), AMITRIPTYLINE HYDROCHLORIDE (EQ 25MG BASE) | ORAL | TABLET | False | 1988-01-12 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE |
| 3 | ANDA070765_001 | discontinued | AMITRIPTYLINE HYDROCHLORIDE (EQ 12.5MG BASE), CHLORDIAZEPOXIDE (5MG) | ORAL | TABLET | False | 1986-12-10 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE |
| 4 | ANDA070766_001 | discontinued | AMITRIPTYLINE HYDROCHLORIDE (EQ 25MG BASE), CHLORDIAZEPOXIDE (10MG) | ORAL | TABLET | False | 1986-12-10 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE |
| 5 | ANDA071297_001 | RX | CHLORDIAZEPOXIDE (10MG), AMITRIPTYLINE HYDROCHLORIDE (EQ 25MG BASE) | ORAL | TABLET | True | 1986-12-10 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE |
| 6 | ANDA071297_002 | RX | CHLORDIAZEPOXIDE (5MG), AMITRIPTYLINE HYDROCHLORIDE (EQ 12.5MG BASE) | ORAL | TABLET | False | 1986-12-10 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE |
| 7 | ANDA072052_001 | discontinued | CHLORDIAZEPOXIDE (5MG), AMITRIPTYLINE HYDROCHLORIDE (EQ 12.5MG BASE) | ORAL | TABLET | False | 1988-12-16 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE |
| 8 | ANDA072053_001 | discontinued | AMITRIPTYLINE HYDROCHLORIDE (EQ 25MG BASE), CHLORDIAZEPOXIDE (10MG) | ORAL | TABLET | False | 1988-12-16 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE |
| 9 | ANDA072277_001 | discontinued | AMITRIPTYLINE HYDROCHLORIDE (EQ 12.5MG BASE), CHLORDIAZEPOXIDE (5MG) | ORAL | TABLET | False | 1988-05-09 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE |
| 10 | ANDA072278_001 | discontinued | AMITRIPTYLINE HYDROCHLORIDE (EQ 25MG BASE), CHLORDIAZEPOXIDE (10MG) | ORAL | TABLET | False | 1988-05-09 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE |
| 11 | NDA016949_001 | discontinued | AMITRIPTYLINE HYDROCHLORIDE (EQ 12.5MG BASE), CHLORDIAZEPOXIDE (5MG) | ORAL | TABLET | False | LIMBITROL | |
| 12 | NDA016949_002 | discontinued | AMITRIPTYLINE HYDROCHLORIDE (EQ 25MG BASE), CHLORDIAZEPOXIDE (10MG) | ORAL | TABLET | False | LIMBITROL |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 22d710ec-302a-4756-95e3-8ee7957586e4 (view SPL) | prescription | Human Prescription | Par Pharmaceutical Companies, Inc. | 2012-06-13 | 4 | 498840265, 498840266 | |
| 2 | 66a756f2-ac77-451c-a19a-08896d73b15c (view SPL) | prescription | Human Prescription | Mylan Pharmaceuticals Inc. | 2014-12-23 | 7 | 003780211, 003780277 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII