Application 050006

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIBRAMYCIN	DOXYCYCLINE	FOR SUSPENSION;ORAL	EQ 25MG BASE/5ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N050006-001	VIBRAMYCIN	DOXYCYCLINE	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050006-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050006-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050006-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050006-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050006-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050006-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050006-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050006-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050006-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050006-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050006-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050006-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050006-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050006-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050006-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050006-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050006-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050006-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050006-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050006-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050006-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050006-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050006-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050006-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050006-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050006-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050006-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050006-001	AB	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.

Matched openFDA labels page 5 of 5 · 97 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	5f989cc1-48ae-41bb-b297-2f8c83760b6d	2024-07-15	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Lannett Company, Inc.	4999bbd9-44ed-4749-9730-be2337bdf490	2024-07-03	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Alembic Pharmaceuticals Limited	8e78dc54-8322-435d-8879-4bfe37f1b98c	2024-07-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	NuCare Pharmaceuticals,Inc.	fa1da527-7a0f-8ed6-e053-6394a90a1b62	2024-02-09	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Proficient Rx LP	c707566b-dbc7-4dac-bad1-952f2f4d6845	2024-02-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Lupin Pharmaceuticals,Inc.	6512bf22-c211-4127-a8c8-2419656580f6	2024-01-30	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	A-S Medication Solutions	6aab6fee-791e-4141-b55f-685ec9d8712a	2023-11-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Proficient Rx LP	b83c4c4b-2885-43e7-b1c9-0b3bbf75528d	2023-10-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Asclemed USA, Inc.	f33ae6f5-bdb6-4c15-9e62-6180433bb1fb	2023-05-04	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Alembic Pharmaceuticals Limited	3dfa486c-4665-4882-93ac-9259708f899c	2023-01-27	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Zydus Lifesciences Limited	6ae11b4e-1c13-440b-a050-d76e062b0f92	2022-11-05		Name fallback generic name: DOXYCYCLINE
Doxycycline Hyclate	DOXYCYCLINE	Proficient Rx LP	e2151005-fb4a-485d-88ad-b44c4594d579	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	b256babb-1bba-4b0c-8837-d13ba3af7659	2021-02-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	a7b754e2-a028-469d-ba95-8412ef03ab0a	2021-02-02	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxy 100	DOXYCYCLINE	Fresenius Kabi USA, LLC	b0894010-39bd-459f-8563-cf83343105ee	2020-06-04	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Proficient Rx LP	f3ba6c30-ada3-4a57-9ff8-30558202b9aa	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Sun Pharmaceutical Industries Inc.	8224b9c5-5c4b-4dda-bc58-47b6604c2884	2018-08-06	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div P	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83082	SUPPL	2025-08-12
83078	SUPPL	2025-08-11
81844	SUPPL	2025-04-08
81788	SUPPL	2025-04-02
61436	SUPPL	2019-12-26
61408	SUPPL	2019-12-23
56668	SUPPL	2018-12-07
56626	SUPPL	2018-12-04
49110	SUPPL	2017-07-28
49091	SUPPL	2017-07-27
46588	SUPPL	2016-12-29
46504	SUPPL	2016-12-21
38905	SUPPL	2016-04-07
29971	SUPPL	2016-04-05
38904	SUPPL	2014-10-02
7684	SUPPL	2014-09-16
17790	SUPPL	2013-09-09
7683	SUPPL	2013-09-09
17789	SUPPL	2013-05-01
7682	SUPPL	2013-04-30
38903	SUPPL	2011-05-16
17788	SUPPL	2008-02-14
29970	SUPPL	2008-02-13
29969	SUPPL	2004-03-16
29968	SUPPL	2002-06-18