Application 213115

Type: ANDA
Sponsor: GRANULES PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	CAPSULE;ORAL	300MG;50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213115-001	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	300MG;50MG	CAPSULE / ORAL	AA		2019-11-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A213115-001	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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213115-001	BUTALBITAL AND ACETAMINOPHEN	300MG;50MG	CAPSULE / ORAL	AA	2019-11-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213115-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213115-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213115-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213115-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213115-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213115-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213115-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213115-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213115-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213115-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213115-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213115-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213115-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213115-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213115-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213115-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213115-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213115-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213115-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213115-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213115-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213115-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213115-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A213115-001	AA	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213115-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213115-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213115-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213115-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213115-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213115-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213115-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213115-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213115-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213115-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213115-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213115-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213115-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213115-001	AA	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A213115-001	CGT	2020-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213115-001	CGT	2020-07-28	`c0c555d07b60…`

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
butalbital and acetaminophen	BUTALBITAL AND ACETAMINOPHEN	Granules Pharmaceuticals Inc.	2091c292-b77b-4ce6-8bba-436c74eee3d7	2023-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213115 application number: ANDA213115 ndc (product): 70010-054

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70010-054	butalbital and acetaminophen	butalbital and acetaminophen	Granules Pharmaceuticals Inc.	ANDA	Current
70010-054	butalbital and acetaminophen	butalbital and acetaminophen	Granules Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63105	ORIG	2020-05-19