Application 200243
- Type
- ANDA
- Sponsor
- LANNETT CO 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 |
|---|---|---|---|---|---|---|---|
| A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200243-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A200243-001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 325MG;50MG;40MG | TABLET / ORAL | AA | 2012-09-13 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A200243-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200243-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200243-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200243-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200243-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200243-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200243-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200243-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200243-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A200243-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200243-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200243-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200243-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A200243-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200243-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A200243-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A200243-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A200243-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A200243-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A200243-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A200243-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A200243-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A200243-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A200243-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A200243-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A200243-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A200243-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A200243-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A200243-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A200243-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A200243-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A200243-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A200243-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A200243-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A200243-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A200243-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A200243-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A200243-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A200243-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A200243-001 | AA | 1 | cb3db0bc1861… |
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 | REMEDYREPACK INC. | bf333509-bf2b-43fa-9eb5-5193e442f328 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 200243 ANDA200243 70518-1134 |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Cardinal Health 107, LLC | ab70f3dc-708e-4455-99ff-a2b9fe2d71a3 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 200243 ANDA200243 |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Major Pharmaceuticals | 0ca49c3c-f2cb-40e3-a7d5-5f48eca59016 | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 200243 ANDA200243 0904-6938 |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | NuCare Pharmaceuticals, Inc. | 4ecb7bdc-4a43-7444-e054-00144ff88e88 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | 200243 ANDA200243 68071-3249 |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Bryant Ranch Prepack | 5b918d6b-94b0-4f9a-ab09-6a511b727de0 | 2024-10-29 | Boxed warning, Warnings, Adverse reactions | 200243 ANDA200243 63629-8392 |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Lannett Company, Inc. | 42594152-563e-4984-9901-d6ef3b8a6941 | 2024-08-05 | Boxed warning, Warnings, Adverse reactions | 200243 ANDA200243 0527-1695 |
| Butal/APAP/Caff | BUTAL/APAP/CAFF | Direct_Rx | f6dc9bbc-3331-b422-e053-6394a90af9a1 | 2024-02-05 | Boxed warning, Warnings, Adverse reactions | 200243 ANDA200243 |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Proficient Rx LP | 7a2219a8-8aaf-44ad-9808-b67923df361a | 2022-02-01 | Boxed warning, Warnings, Adverse reactions | 200243 ANDA200243 63187-933 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-1695 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Lannett Company, Inc. | ANDA | Current |
| 0527-1695 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Lannett Company, Inc. | ANDA | Current |
| 0527-1695 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Lannett Company, Inc. | ANDA | Current |
| 0527-1695 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Lannett Company, Inc. | ANDA | Current |
| 0904-6938 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Major Pharmaceuticals | ANDA | Current |
| 0904-6938 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Major Pharmaceuticals | ANDA | Current |
| 33358-059 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | RxChange Co. | ANDA | Current |
| 45865-352 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Medsource Pharmaceuticals | ANDA | Current |
| 45865-352 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Medsource Pharmaceuticals | ANDA | Current |
| 50090-2564 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | A-S Medication Solutions | ANDA | Current |
| 50436-1695 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Unit Dose Services | ANDA | Current |
| 53002-6030 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-6030 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-662 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-662 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-662 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 63187-933 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Proficient Rx LP | ANDA | Current |
| 63187-933 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Proficient Rx LP | ANDA | Current |
| 63187-933 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Proficient Rx LP | ANDA | Current |
| 63187-933 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Proficient Rx LP | ANDA | Current |
| 63629-8392 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Bryant Ranch Prepack | ANDA | Current |
| 68071-3120 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3249 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3249 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6939 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1134 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1134 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1134 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1134 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1134 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1134 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | REMEDYREPACK INC. | ANDA | Current |
| 71335-0365 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0365 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0365 | Butalbital, Acetaminophen, and Caffeine | Butalbital, Acetaminophen, and Caffeine | Bryant Ranch Prepack | ANDA | Current |