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N050006-001	VIBRAMYCIN	DOXYCYCLINE	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982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N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`84e616aacf4f…`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N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`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UTC	2026-02	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`011fe1cb6892…`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ZIP	2025-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`31067a03dcf5…`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 2 of 5 · 97 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxycycline	DOXYCYCLINE	PD-Rx Pharmaceuticals, Inc.	dedebcb4-3c3f-4487-a488-36af12640c92	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	DIRECT RX	31512ece-cb16-2a9a-e054-00144ff88e88	2026-03-05	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	American Health Packaging	3fbf4bb8-036e-41d3-9628-476fc05ddd31	2026-02-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	A-S Medication Solutions	1c998ca8-1df6-4b3c-9533-f4500cc1079a	2026-02-10	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	A-S Medication Solutions	2c7795c9-9e4e-477a-ad9f-01e4c55c06b6	2026-02-10	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	6285181d-e34d-4def-abe6-2c41254ada75	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	JVET PHARMACEUTICALS LLC	ed95709e-2a1a-4deb-88bd-5b99f02b7a26	2026-01-27	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Par Health USA, LLC	acb84610-5e26-4b0c-89e5-42bc0f8fa00d	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	AiPing Pharmaceutical, Inc.	a894f4be-19e5-4785-8d0b-5e0d5626300e	2026-01-12	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	AvPAK	a5b28a41-db12-af7c-e053-2995a90ace09	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Proficient Rx LP	112c35d6-a397-45de-a57a-6e687cb27b4f	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Northwind Health Company, LLC	f2f1ee15-9323-1263-e053-2995a90a01fa	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Northwind Health Company, LLC	f3319f4f-b535-da12-e053-2995a90ac00f	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Health Department, Oklahoma State	f39365f9-eb64-00cb-e053-2995a90a8d80	2025-12-31	Warnings	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Chartwell RX, LLC	5bebf320-1395-43b9-9404-fe479d70b240	2025-12-09	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Strides Pharma Science Limited	3b9888a2-ca16-43f7-ab6d-f03188ec2c0d	2025-12-02	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Camber Pharmaceuticals, Inc.	0faee97d-2707-48fe-a739-143cd1a1c4e3	2025-11-27	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline Hyclate	DOXYCYCLINE	Bryant Ranch Prepack	f9a9a558-4063-4aa7-9191-3875c97cf49a	2025-11-19	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Steriscience Specialties Private Limited	6d1f7b0f-b71d-4cee-803b-fe418d000c9c	2025-11-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Cranbury Pharmaceuticals, LLC	43ceb0ee-268a-424c-a6a8-88e824c5ed04	2025-11-04	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