Application 203347

Type: ANDA
Sponsor: HETERO LABS UNIT III

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MARAVIROC	MARAVIROC	TABLET;ORAL	150MG	No	No
002	MARAVIROC	MARAVIROC	TABLET;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A203347-001	MARAVIROC	MARAVIROC	150MG	TABLET / ORAL	AB		2022-02-07
A203347-002	MARAVIROC	MARAVIROC	300MG	TABLET / ORAL	AB		2022-02-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203347-001	AB
A203347-002	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 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203347-001	MARAVIROC	150MG	TABLET / ORAL	AB	2022-02-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203347-002	MARAVIROC	300MG	TABLET / ORAL	AB	2022-02-07	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203347-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203347-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203347-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203347-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203347-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203347-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203347-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203347-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203347-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203347-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203347-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203347-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203347-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203347-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203347-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203347-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203347-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203347-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203347-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203347-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203347-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203347-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203347-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203347-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203347-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203347-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203347-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203347-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203347-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203347-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203347-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203347-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203347-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203347-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203347-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203347-002	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203347-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203347-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203347-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203347-002	AB	1	`1c564ffb4f44…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203347-001	PC	2022-08-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203347-002	PC	2022-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203347-001	PC	2022-08-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203347-002	PC	2022-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203347-001	PC	2022-08-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203347-002	PC	2022-08-06	`4b0b4de00fa7…`
2023-01-26 05:58 UTC	2023-01	A203347-001	PC	2022-08-06	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A203347-002	PC	2022-08-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203347-001	PC	2022-08-06	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203347-002	PC	2022-08-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203347-001	PC	2022-08-06	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A203347-002	PC	2022-08-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203347-001	PC	2022-08-06	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A203347-002	PC	2022-08-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203347-001	PC	2022-08-06	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203347-002	PC	2022-08-06	`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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Maraviroc	MARAVIROC	A-S Medication Solutions	0c5f41e8-d358-403a-b199-6b9028b52748	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203347 application number: ANDA203347
Maraviroc	MARAVIROC	Hetero Labs Limited	9db91945-127e-4bb6-970a-ff1e36dde658	2024-07-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203347 application number: ANDA203347
Maraviroc	MARAVIROC	XLCare Pharmaceuticals Inc.	d3a728e2-1866-462e-bfcc-5f3c9dd88794	2023-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203347 application number: ANDA203347
Maraviroc	MARAVIROC	Camber Pharmaceuticals, Inc.	09ec3e79-c0d3-4b8f-80d8-0a854c4ca339	2022-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203347 application number: ANDA203347 ndc (product): 31722-580 ndc (product): 31722-579

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-579	Maraviroc	Maraviroc	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-580	Maraviroc	Maraviroc	Camber Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71713	ORIG	2022-08-04