Application 050786

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PYLERA	BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE	CAPSULE;ORAL	140MG;125MG;125MG	Yes	Yes

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
N050786-001	PYLERA	BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050786-001	AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
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	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL	AB	RLD, RS	2006-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050786-001	PYLERA	140MG;125MG;125MG	CAPSULE / ORAL		RLD, RS	2006-09-28	`cb3db0bc1861…`

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	N050786-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050786-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050786-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050786-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050786-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050786-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050786-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050786-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050786-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050786-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050786-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050786-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050786-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050786-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050786-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050786-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050786-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050786-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050786-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050786-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050786-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050786-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050786-001	AB	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PYLERA	BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE	H2-Pharma, LLC	5cdacbf5-67be-42eb-bd54-8acc32ea1abc	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050786 application number: NDA050786
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride	BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	H2-Pharma, LLC	c29bfde9-5eb4-422a-bd30-4bce45e73dc0	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050786 application number: NDA050786
PYLERA	BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE	H2-Pharma, LLC	c50626a2-5969-490b-a88a-a4ee45e79615	2026-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050786 application number: NDA050786

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58914-601	Pylera	Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride	Allergan, Inc.	NDA	Current
58914-601	Pylera	Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride	Allergan, Inc.	NDA	Current
58914-601	Pylera	Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride	Allergan, Inc.	NDA	Current
58914-601	Pylera	Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84335	SUPPL	2025-11-28
84326	SUPPL	2025-11-28
81855	SUPPL	2025-04-08
81787	SUPPL	2025-04-02
79679	SUPPL	2024-09-23
79666	SUPPL	2024-09-20
79027	SUPPL	2024-07-09
79012	SUPPL	2024-07-09
69701	SUPPL	2021-12-21
69614	SUPPL	2021-12-17
66688	SUPPL	2021-03-09
66659	SUPPL	2021-03-09
55893	SUPPL	2018-10-11
55858	SUPPL	2018-10-10
52426	SUPPL	2018-02-06
52095	SUPPL	2018-01-30
48637	SUPPL	2017-06-02
48615	SUPPL	2017-06-01
46998	SUPPL	2017-01-27
46974	SUPPL	2017-01-25
30545	SUPPL	2013-01-25
39335	SUPPL	2013-01-24
8291	SUPPL	2011-01-24
30544	SUPPL	2007-05-29
18248	SUPPL	2007-05-29
42738	ORIG	2006-11-22
30543	ORIG	2006-10-02