Application 211012

Type: ANDA
Sponsor: AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	CAPSULE;ORAL	EQ 50MG BASE	No	No
002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	CAPSULE;ORAL	EQ 100MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211012-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL			2018-09-24
A211012-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL			2018-09-24

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211012-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2018-09-24	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211012-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2018-09-24	`3a93d1ddd44b…`

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
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Ajanta Pharma USA Inc.	f18daceb-33a3-4931-9be7-ecd6356cc119	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211012 application number: ANDA211012 ndc (product): 27241-141 ndc (product): 27241-140

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-140	Doxycycline Hyclate	Doxycycline Hyclate	Ajanta Pharma USA Inc.	ANDA	Current
27241-140	Doxycycline Hyclate	Doxycycline Hyclate	Ajanta Pharma Limited	ANDA	Current
27241-140	Doxycycline Hyclate	Doxycycline Hyclate	Ajanta Pharma Limited	ANDA	Current
27241-141	Doxycycline Hyclate	Doxycycline Hyclate	Ajanta Pharma USA Inc.	ANDA	Current
27241-141	Doxycycline Hyclate	Doxycycline Hyclate	Ajanta Pharma Limited	ANDA	Current
27241-141	Doxycycline Hyclate	Doxycycline Hyclate	Ajanta Pharma Limited	ANDA	Current