Application 088616
- Type
- ANDA
- Sponsor
- ACTAVIS LABS UT INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | TABLET;ORAL | 325MG;50MG;40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A088616-001 | AA |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 1984-11-09 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088616-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | RLD | 1984-11-09 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A088616-001 | AA | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A088616-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A088616-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A088616-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088616-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A088616-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088616-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088616-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088616-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088616-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088616-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088616-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A088616-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088616-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088616-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088616-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A088616-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088616-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A088616-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A088616-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A088616-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A088616-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A088616-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088616-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A088616-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A088616-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A088616-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A088616-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A088616-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A088616-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088616-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A088616-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A088616-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088616-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088616-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088616-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088616-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A088616-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A088616-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088616-001 | AA | 1 | 3a93d1ddd44b… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | QUAGEN PHARMACEUTICALS LLC | 8438f08f-a32a-4180-9030-e0fd5da4be30 | 2024-05-07 | Boxed warning, Warnings, Adverse reactions | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | QUAGEN PHARMACEUTICALS LLC | 24813ec6-0111-4782-9182-a2b93501a2bc | 2024-05-06 | Boxed warning, Warnings, Adverse reactions | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | e9dffed5-d615-4e63-9860-c0f6f23848a1 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | KVK-Tech, Inc. | 7f9c4668-4f4a-453b-b2fa-a6fed903ddfa | 2024-02-16 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| butalbital, acetaminophen and caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | 6a593fc7-49b0-4910-8a0c-5e718e5ff45b | 2024-01-31 | Boxed warning, Warnings, Adverse reactions | butalbital, acetaminophen and caffeine |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Seton Pharmaceuticals LLC | 3c5cefe3-c84e-4380-97f3-78e3fe92543a | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| butalbital, acetaminophen and caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Mikart, LLC | a26775c2-cafb-4b13-99ac-d4e8248265fb | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | butalbital, acetaminophen and caffeine |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Granules Pharmaceuticals Inc. | 2407efce-b77e-4072-bc4b-62c789d01e1a | 2023-12-04 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | b94ab2bc-6ef3-4a64-ba05-a0a4e37794fa | 2023-11-30 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | 6e28cc29-a85a-44d0-9c5b-bd0934ece64d | 2023-11-30 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | QUAGEN PHARMACEUTICALS LLC | 5f3c7457-6670-4a0d-bdff-c3e0fe91b7c6 | 2023-07-10 | Boxed warning, Warnings, Adverse reactions | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
| butalbital, acetaminophen and caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | 3875c01b-7cd6-4bed-8d4e-c580c5540860 | 2023-04-11 | Boxed warning, Warnings, Adverse reactions | butalbital, acetaminophen and caffeine |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Golden State Medical Supply, Inc. | ee131bce-863b-b5a1-e053-2a95a90afc79 | 2023-03-16 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Granules Pharmaceuticals Inc. | 74e27dab-9790-47e4-b4f1-3b9df4bce184 | 2023-01-27 | Boxed warning, Warnings, Adverse reactions | Butalbital, Acetaminophen and Caffeine |
| butalbital, acetaminophen and caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Proficient Rx LP | 1bde13a5-cdd4-4bc2-8aeb-32e4dc157293 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | butalbital, acetaminophen and caffeine |
| butalbital, acetaminophen and caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Lannett Company, Inc. | c1107153-494b-4068-8500-96bc241187a5 | 2019-06-01 | Boxed warning, Warnings, Adverse reactions | butalbital, acetaminophen and caffeine |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0591-3369 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3369 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Actavis Pharma, Inc. | ANDA | Current |
| 49999-151 | Butalbital Acetaminophen and Caffeine | Butalbital Acetaminophen and Caffeine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-0371 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | A-S Medication Solutions | ANDA | Current |
| 50436-3369 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Unit Dose Services | ANDA | Current |
| 55154-3416 | Fioricet | Butalbital, Acetaminophen, and Caffeine | Cardinal Health | ANDA | Current |
| 68788-9287 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Preferred Pharmaceuticals Inc. | ANDA | Current |