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N050006-001	VIBRAMYCIN	DOXYCYCLINE	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982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N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`84e616aacf4f…`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N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`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UTC	2026-02	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`011fe1cb6892…`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ZIP	2025-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`31067a03dcf5…`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 3 of 5 · 97 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXYCYCLINE	DOXYCYCLINE	Henry Schein, Inc	dd70368b-1949-4833-9d1e-f9f4cdacd9f3	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Lupin Pharmaceuticals, Inc.	e0e80435-1b6a-4361-8c8a-e432f8f23a1b	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE DOXYCYCLINE	DOXYCYCLINE	Dr. Reddy's Laboratories, Inc.	c0206e91-d87f-311c-80dc-aad543d001e8	2025-10-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Solco Healthcare US,LLC	99305d9a-d058-45d6-8dec-19308b1fc5a9	2025-09-30	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Chartwell Governmental & Specialty RX, LLC	b8486639-7eb9-4610-9cd4-0e922045d592	2025-09-30	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Chartwell RX LLC	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	2025-09-30	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Piramal Critical Care Inc	fd672959-014f-8300-e053-6394a90a5ec5	2025-09-23	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline Hyclate	DOXYCYCLINE	Amneal Pharmaceuticals NY LLC	49ecbf95-58e8-4f3c-b5d5-650a15d866cb	2025-09-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline Hyclate	DOXYCYCLINE	Amneal Pharmaceuticals NY LLC	79f3c026-7687-4a11-8d2e-03493531d3bf	2025-09-10	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Strides Pharma Science Limited	d27c58a1-5c99-4007-9bc6-ad9b6fb56db8	2025-09-03	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	AvKARE	3dd8c11c-aa52-9e22-e063-6294a90a5cbd	2025-09-02	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Proficient Rx LP	00ea3641-18da-4a6f-a779-e16075464d2b	2025-09-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	2bcde264-5f6f-47f6-ae2e-1b7010deacf7	2025-07-18	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Alembic Pharmaceuticals Inc.	a50e953d-447b-4b66-b567-04586174d3f9	2025-06-16	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Macleods Pharmaceuticals Limited	10aca485-850b-4c82-bb7e-5fac2d7a62ce	2025-06-07	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Dr.Reddys Laboratories Inc	7a28cce1-4805-b3d1-4484-e7a49c597660	2025-06-06	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Lupin Pharmaceuticals, Inc.	81c5a7fc-3fe0-40b2-bae0-c79eb0b27697	2025-06-04	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	b46208a2-5072-4df5-b2af-379f865545d2	2025-06-02	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	A-S Medication Solutions	2b3b3c48-eb60-400c-bdfe-50635a136c90	2025-05-28	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Zydus Pharmaceuticals USA Inc.	fef9580d-8850-4cbb-89eb-2b4d40ee59c9	2025-04-26	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